Endoscopic closure devices

Abstract

The ASGE Technology Committee provides reviews of new or emerging endoscopic technologies that have the potential to affect the practice of GI endoscopy. Evidence-based methodology is used, with a MEDLINE literature search to identify pertinent preclinical and clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the “related articles” feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but in many cases, data from randomized, controlled trials are lacking. In such cases, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. For this review, the MEDLINE database was searched through October 2011 using the keywords “enterotomy,” “gastrotomy,” “colostomy,” “perforation,” “fistula,” “natural orifice transluminal endoscopic surgery,” “closure,” “endoscopic suturing,” “endoscopic clipping,” and “placating.” Reports on Emerging Technologies are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. These reports are scientific reviews provided solely for educational and informational purposes. Reports on Emerging Technologies are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment. Nonsurgical closure of the GI wall may be desired in the setting of inflammatory or neoplastic fistulae, dehiscence of surgical anastomoses, and spontaneous or iatrogenic perforations. Closure is also necessary after natural orifice translumenal endoscopic surgery (NOTES®). Several devices and techniques are being developed to allow endoscopic closure of these GI wall defects. The ideal closure device should be inexpensive, safe, and easy to use. It should provide rapid, reliable closure, which is both robust and durable, and should also be effective in the closure of larger defects. Among the first endoscopic devices used for the closure of small perforations were endoscopic clips.1Binmoeller K.F. Grimm H. Soehendra N. Endoscopic closure of a perforation using metallic clips after snare excision of a gastric leiomyoma.Gastrointest Endosc. 1993; 39: 172-174Abstract Full Text PDF PubMed Scopus (164) Google Scholar Clips were discussed in a previous technology committee document.2Chuttani R. Barkun A. Carpenter S. et al.Endoscopic clip application devices.Gastrointest Endosc. 2006; 63: 746-750Abstract Full Text Full Text PDF PubMed Scopus (86) Google Scholar Although endoscopic clips may provide an adequate closure solution for small defects, they are less useful for larger defects because of the restricted opening distance between their jaws, low closure force, and inability to accomplish deep-tissue capture. These deficiencies are particularly troublesome when trying to use endoscopic clips in the setting of the inflamed, indurated, and fibrotic tissue associated with chronic fistulae. Case reports and small case series also describe successful closure of perforations, fistulae, and anastomotic leaks by using tissue glues and covered self-expandable metal stents.3Bethge N. Kleist D.V. Vakil N. Treatment of esophageal perforation with a covered expandable metal stent.Gastrointest Endosc. 1996; 43: 161-163Abstract Full Text Full Text PDF PubMed Scopus (30) Google Scholar, 4Langer F.B. Wenzl E. Prager G. et al.Management of postoperative esophageal leaks with the Polyflex self-expanding covered plastic stent.Ann Thorac Surg. 2005; 79 (discussion 404): 398-403Abstract Full Text Full Text PDF PubMed Scopus (191) Google Scholar, 5Mutignani M. Iacopini F. Dokas S. et al.Successful endoscopic closure of a lateral duodenal perforation at ERCP with fibrin glue.Gastrointest Endosc. 2006; 63: 725-727Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar However, these too provide an inadequate and unreliable solution. An unmet need has therefore persisted for a reliable and robust endoscopic solution for the closure of mural defects, both spontaneous and iatrogenic. With the development of NOTES as a new and potentially viable surgical platform, there has been an increasing interest and immediacy in the need to develop dedicated devices and techniques that allow closure of enterotomies. Although many endoscopic closure devices have undergone testing and evaluation in bench and animal models, only a few have been used in human subjects and only 2 are being actively marketed in the United States at this time. An over-the-scope clip (OTSC) (Ovesco, Tübingen, Germany) has been developed for the closure of small mural defects and bleeding ulcers.6Kirschniak A. Kratt T. Stuker D. et al.A new endoscopic over-the-scope clip system for treatment of lesions and bleeding in the GI tract: first clinical experiences.Gastrointest Endosc. 2007; 66: 162-167Abstract Full Text Full Text PDF PubMed Scopus (262) Google Scholar In animal models, reliable full-thickness closure of defects of as large as 27 mm was achieved with this device.7von Renteln D. Schmidt A. Vassiliou M.C. et al.Endoscopic full-thickness resection and defect closure in the colon.Gastrointest Endosc. 2010; 71: 1267-1273Abstract Full Text Full Text PDF PubMed Scopus (70) Google Scholar The OTSC produces more durable closure than standard endoclips8von Renteln D. Vassiliou M.C. Rothstein R.I. Randomized controlled trial comparing endoscopic clips and over-the-scope clips for closure of natural orifice transluminal endoscopic surgery gastrotomies.Endoscopy. 2009; 41: 1056-1061Crossref PubMed Scopus (131) Google Scholar because of its ability to grasp more tissue, include the entire thickness of the visceral wall, and apply a greater compressive force. The OTSC received Conformite Europeene certification in Europe in 2009 and 510(k) clearance by the U.S. Food and Drug Administration (FDA) in 2010. The device includes an applicator cap, a nitinol clip, and a hand wheel (Fig. 1) . The applicator cap, with a mounted nitinol clip, is affixed to the tip of the endoscope in a manner similar to that of a variceal band-ligation cap. The clip fits onto the cylindrical cap in the open position. Caps are available in 3 diameters to accommodate various endoscope diameters: 11 mm (designed for endoscope diameters 9.5-11 mm), 12 mm (for endoscope diameters 10.5-12 mm), and 14 mm (for endoscope diameters 11.5-14 mm). With the applicator cap attached to the endoscope, the corresponding outer diameter of the instrument is 16.5, 17.5, or 21 mm. Caps are also available in 2 depths (3 and 6 mm) to allow variation in the amount of tissue grasped during approximation. Clips come in 3 different sizes to match the cap sizes and also with 3 different shapes of teeth (Fig. 2) : type a (rounded), type t (pointed), and type gc (longer pointed). Clips with rounded teeth are used where the goal is tissue compression for hemostasis, particularly in the thinner walled esophagus and colon. Pointed teeth improve tissue capture and decrease the risk of the clip slipping in indurated or fibrotic tissue and are used for perforation and fistula closure. Clip type gc with longer pointed teeth was designed for use in the thicker walled stomach.Figure 2Over-the-scope clips: type a (rounded) (left), type t (pointed) (middle), and type gc (longer pointed) (right).View Large Image Figure ViewerDownload Hi-res image Download (PPT) The applicator cap incorporates a clip release thread, which is pulled retrogradely through the working channel of the endoscope and fixed onto a hand wheel mounted on the working-channel access port of the endoscope. The clip is released by turning the hand wheel, in a manner similar to deploying a variceal ligation band. On deployment, the clip returns to its baseline closed shape, capturing and compressing the tissue that was suctioned into the applicator cap. The deployed clips deliver enough compression force to allow firm apposition. Smaller defects can be closed by merely suctioning the defect and surrounding tissue into the cap, followed by clip deployment. Larger defects require one of the assist devices described in the following. Three additional instruments are available separately that facilitate use of the OTSC. This device assists in mounting additional clips onto the applicator cap after deployment of the initial clip. Use of this device is only necessary if more than 1 clip is placed in the same treatment session. This device, which enables the user to grasp opposite edges of the defect sequentially and pull them together, facilitates apposition of the tissue before clip deployment. It is particularly useful for larger defects and for chronic defects associated with indurated tissue where suction alone may be inadequate to approximate tissue. It is available in flexible catheter lengths of 165 and 220 cm for use with gastroscopes and colonoscopes, respectively. An endoscope working channel of at least 3.2 mm is required to use this device, which is advanced along side the clip release thread. The device has 2 lateral, independently controlled, hinged, mobile jaws that can be apposed against an immobile, common central jaw, thereby allowing tissue approximation. The approximated tissue is then pulled into the applicator cap, additional suction applied if necessary, and the clip is then deployed by turning the hand wheel. This device is used to retract fibrotic tissue (eg, chronic fistulae and ulcers) into the cap when simple suction or the twin grasper may not be effective.9von Renteln D. Denzer U.W. Schachschal G. et al.Endoscopic closure of GI fistulae by using an over-the-scope clip (with videos).Gastrointest Endosc. 2010; 72: 1289-1296Abstract Full Text Full Text PDF PubMed Scopus (94) Google Scholar This accessory consists of a 165-cm long flexible catheter with 3 retractable needle pins. When released, the 3 pins pierce tissue along a curved path, thereby anchoring it. The tissue can then be pulled into the applicator cap, suction applied if necessary, and the clip deployed. The anchor is then retracted and removed. An endoscope working channel of at least 3.2 mm is required to use this device with the OTSC system. The Overstitch endoscopic suturing system (Apollo Endosurgery, Austin, Tex) is a disposable, single-use suturing device that is mounted onto a double-channel therapeutic endoscope and allows placement of either running or interrupted full-thickness sutures (Figure 3, Figure 4). The device represents an evolution of the previously described Eagle Claw device.10Chiu P.W. Hu B. Lau J.Y. et al.Endoscopic plication of massively bleeding peptic ulcer by using the Eagle Claw VII device: a feasibility study in a porcine model.Gastrointest Endosc. 2006; 63: 681-685Abstract Full Text Full Text PDF PubMed Scopus (34) Google Scholar, 11Hu B. Chung S.C. Sun L.C. et al.Eagle Claw II: a novel endosuture device that uses a curved needle for major arterial bleeding: a bench study.Gastrointest Endosc. 2005; 62: 266-270Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar A drawback is that it is only compatible with a single endoscope, the Olympus 2T160. The device obtained FDA 510(k) clearance in 2008. The initially marketed Overstitch device had multiple parts and was therefore relatively more complex to put together and use. The new version, released in October 2011, has been significantly simplified.Figure 4Overstitch: helix device.View Large Image Figure ViewerDownload Hi-res image Download (PPT) The device comprises 3 main parts: the end cap, the needle driver handle, and an anchor exchange catheter. Additional necessary assist components include a suture cassette, a cinching device, a helix device, and an overtube. The end cap, attached to the distal tip of the endoscope, houses a hinged, curved, hollow needle body that opens and closes in an arc. The needle driver handle opens and closes the suture arm. The suture cassette contains a suture that is attached to a tissue anchor, which serves as a T tag. Both absorbable (2-0 and 3-0 polydioxanone) and nonabsorbable (2-0 and 3-0 polypropylene) sutures are available. The tissue anchor attaches to the suture arm and acts as the tip of the suturing needle. Once a suture has been positioned through tissue, the anchor exchange catheter allows the tip of the needle to be retracted so that additional tissue can be pierced. The Amplatzer Septal Occluder (AGA Medical Group, Plymouth, Minn) is a device developed for occlusion of cardiac septal defects. However, the device has been used off-label for the closure of GI fistulae.12Melmed G.Y. Kar S. Geft I. et al.A new method for endoscopic closure of gastrocolonic fistula: novel application of a cardiac septal defect closure device (with video).Gastrointest Endosc. 2009; 70: 542-545Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar, 13Coppola F. Boccuzzi G. Rossi G. et al.Cardiac septal umbrella for closure of a tracheoesophageal fistula.Endoscopy. 2010; 42: E318-E319Crossref PubMed Scopus (23) Google Scholar, 14Repici A. Presbitero P. Carlino A. et al.First human case of esophagus-tracheal fistula closure by using a cardiac septal occluder (with video).Gastrointest Endosc. 2010; 71: 867-869Abstract Full Text Full Text PDF PubMed Scopus (46) Google Scholar, 15Lee H.J. Jung E.S. Park M.S. et al.Closure of a gastrotracheal fistula using a cardiac septal occluder device.Endoscopy. 2011; 43: E53-E54Crossref PubMed Scopus (15) Google Scholar This dumbbell-shaped device consists of 2 self-expandable disks composed of nitinol mesh with polyester fabric connected by a short waist. It is constrained within a 70-cm delivery catheter and deployed over an endoscopically placed guidewire similar to a self-expandable metal stent. The delivery catheter is too short to be passed through an endoscope, but the device can be deployed under direct visualization by passing the endoscope alongside it. After implantation, the device apposes the wall on each side of the defect, mechanically occluding it and potentially creating a platform for subsequent tissue ingrowth. The devices are available in a variety of waist diameters and waist lengths to allow closure of a range of defects. Selection of an appropriately sized device can be aided by sizing the mural defect by inflation of balloons of known diameter. These devices are detailed in TABLE 1, TABLE 2, TABLE 3.TABLE 1Endoscopic closure techniquesTechniqueDescriptionAssist devicesAnimal studiesTrial of no closure of defectGastric puncture dilated with balloon. Because there is dilation only, the muscularis approximates edges and closes defect.NonePorcine,16Jagannath S.B. Kantsevoy S.V. Vaughn C.A. et al.Peroral transgastric endoscopic ligation of fallopian tubes with long-term survival in a porcine model.Gastrointest Endosc. 2005; 61: 449-453Abstract Full Text Full Text PDF PubMed Scopus (366) Google Scholar canine17Bergman S. Fix D.J. Volt K. et al.Do gastrotomies require repair after endoscopic transgastric peritoneoscopy? A controlled study.Gastrointest Endosc. 2010; 71: 1013-1017Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar survivalSelf-approximating tunnel/flapSubmucosal tunnel with exit site distant from mucosal entry site; mucosa closed with clips.Endoscopic hemostatic clipsPorcine gastric,18Yoshizumi F. Yasuda K. Kawaguchi K. et al.Submucosal tunneling using endoscopic submucosal dissection for peritoneal access and closure in natural orifice transluminal endoscopic surgery: a porcine survival study.Endoscopy. 2009; 41: 707-711Crossref PubMed Scopus (61) Google Scholar, 19Pauli E.M. Moyer M.T. Haluck R.S. et al.Self-approximating transluminal access technique for natural orifice transluminal endoscopic surgery: a porcine survival study (with video).Gastrointest Endosc. 2008; 67: 690-697Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar and esophageal20Sumiyama K. Gostout C.J. Rajan E. et al.Pilot study of transesophageal endoscopic epicardial coagulation by submucosal endoscopy with the mucosal flap safety valve technique (with videos).Gastrointest Endosc. 2008; 67: 497-501Abstract Full Text Full Text PDF PubMed Scopus (55) Google Scholar closureGastropexy methodGastrotomy is pulled up to anterior abdominal wall and sutured in place with transmural T tags or other sutures.Endoscopic grasping forceps, T tagsPorcine survival21Sporn E. Miedema B.W. Astudillo J.A. et al.Gastrotomy creation and closure for NOTES using a gastropexy technique (with video).Gastrointest Endosc. 2008; 68: 948-953Abstract Full Text Full Text PDF PubMed Scopus (23) Google ScholarOmentoplasty methodOmental patch is pulled into gastric defect to plug hole, and is fixed in place with clips.Endoscopic hemostatic clips and forcepsPorcine survival22Dray X. Giday S.A. Buscaglia J.M. et al.Omentoplasty for gastrotomy closure after natural orifice transluminal endoscopic surgery procedures (with video).Gastrointest Endosc. 2009; 70: 131-140Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar Open table in a new tab TABLE 2Endoscopic closure devices: animal studiesDeviceCompanyDescriptionAssist devicesAnimal studiesAdaption of older devices designed for other use Bioabsorbable plugsW.L. Gore & Associates, Flagstaff, ArizGore bioabsorbable hernia plug, a plug made from biodegradable polymerPlaced surgically in a proof-of-concept studyCanine survival23Cios T.J. Reavis K.M. Renton D.R. et al.Gastrotomy closure using bioabsorbable plugs in a canine model.Surg Endosc. 2008; 22: 961-966Crossref PubMed Scopus (25) Google Scholar Cardiac septal occluderAGA Medical, Plymouth, MinnNitinol, dumbbell-shaped plug with polyethylene terephthalate sewn-in patchNonePorcine survival24Perretta S. Sereno S. Forgione A. et al.A new method to close the gastrotomy by using a cardiac septal occluder: long-term survival study in a porcine model.Gastrointest Endosc. 2007; 66: 809-813Abstract Full Text Full Text PDF PubMed Scopus (74) Google Scholar Mucosal clipsOlympus, Center Valley, Pa; Boston Scientific, Natick, MassEndoscopic hemostatic clips used to approximate tissue for closureNone or endoscopic grasping forcepsPorcine survival25Merrifield B.F. Wagh M.S. Thompson C.C. Peroral transgastric organ resection: a feasibility study in pigs.Gastrointest Endosc. 2006; 63: 693-697Abstract Full Text Full Text PDF PubMed Scopus (231) Google Scholar, 26Dray X. Krishnamurty D.M. Donatelli G. et al.Gastric wall healing after NOTES procedures: closure with endoscopic clips provides superior histological outcome compared with threaded tags closure.Gastrointest Endosc. 2010; 72: 343-350Abstract Full Text Full Text PDF PubMed Scopus (24) Google Scholar EndoloopsOlympusDefect gathered up and sealed with endoloops alone or in combination with clips or endoscopic hernia tacksEndoscopic grasping forceps, clips, hernia tacksPorcine survival27Hucl T. Benes M. Kocik M. et al.A novel double-endoloop technique for natural orifice transluminal endoscopic surgery gastric access site closure.Gastrointest Endosc. 2010; 71: 806-811Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar, 28Hookey L.C. Bielawska B. Samis A. et al.A reliable and safe gastrotomy closure technique assessed in a porcine survival model pilot study: success of the Queen's closure.Endoscopy. 2009; 41: 493-497Crossref PubMed Scopus (11) Google Scholar, 29Lee S.S. Oelschlager B.K. Wright A.S. et al.Assessment of a simple, novel endoluminal method for gastrotomy closure in NOTES.Surg Endosc. 2011; 25: 3448-3452Crossref PubMed Scopus (5) Google Scholar, 30Bhat Y.M. Hegde S. Knaus M. et al.Transluminal endosurgery: novel use of endoscopic tacks for the closure of access sites in natural orifice transluminal endoscopic surgery (with videos).Gastrointest Endosc. 2009; 69: 1161-1166Abstract Full Text Full Text PDF PubMed Scopus (27) Google Scholar Tissue anchorsCook Endoscopy, Winston-Salem, NC; Ethicon Endosurgery, Cincinati, Ohio; other noncommercial groupsT bars and other types of anchors placed transmurally and cinched or sutured in place to effect closureEndoscopic graspers, needlesPorcine gastric explants and porcine survival studies31Dray X. Gabrielson K.L. Buscaglia et al.Air and fluid leak tests after NOTES procedures: a pilot study in a live porcine model (with videos).Gastrointest Endosc. 2008; 68: 513-519Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar, 32Sumiyama K. Gostout C.J. Rajan E. et al.Endoscopic full-thickness closure of large gastric perforations by use of tissue anchors.Gastrointest Endosc. 2007; 65: 134-139Abstract Full Text Full Text PDF PubMed Scopus (89) Google Scholar, 33Park P.O. Bergstrom M. Rothstein R. et al.Endoscopic sutured closure of a gastric natural orifice transluminal endoscopic surgery access gastrotomy compared with open surgical closure in a porcine model A randomized, multicenter controlled trial.Endoscopy. 2010; 42: 311-317Crossref PubMed Scopus (24) Google Scholar, 34Guarner-Argente C. Cordova H. et al.Gastrotomy closure with a new tissue anchoring device: a porcine survival study.World J Gastroenterol. 2011; 17: 1732-1738Crossref PubMed Scopus (7) Google Scholar, 35Trunzo J.A. Cavazzola L.T. Elmunzer B.J. et al.Facilitating gastrotomy closure during natural-orifice transluminal endoscopic surgery using tissue anchors.Endoscopy. 2009; 41: 487-492Crossref PubMed Scopus (15) Google ScholarNew dedicated experimental devices Looped (connected) T anchorsCook EndoscopyT tags have a small metal loop on the cross piece. Multiple tags can be loaded on 1 suture, and when tension is applied, a purse-string closure is obtainedFriction-fit collar or other cinching devicePorcine survival36Romanelli J.R. Desilets D.J. Chapman C.N. et al.Loop-anchor purse-string closure of gastrotomy in NOTES(R) procedures: survival studies in a porcine model.Surg Innov. 2010; 17: 312-317Crossref PubMed Scopus (5) Google Scholar, 37Willingham F.F. Turner B.G. Gee D.W. et al.Leaks and endoscopic assessment of break of integrity after NOTES gastrotomy: the LEAKING study, a prospective, randomized, controlled trial.Gastrointest Endosc. 2010; 71: 1018-1024Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar OTSCsAponos, Kingston, NHOTSC nitinol clip shaped like 6-point star. Internal prongs gather defect together and keep it closedEndoscopic grasping forceps, delivery pod, T tags as neededPorcine survival38Desilets D.J. Romanelli J.R. Earle D.B. et al.Gastrotomy closure with the lock-it system and the Padlock-G clip: a survival study in a porcine model.J Laparoendosc Adv Surg Tech A. 2010; 20: 671-676Crossref PubMed Scopus (17) Google Scholar Flexible linear staplerPower Medical, (now owned by Covidien, New Haven, Conn)Defect closed by gathering it into jaws of flexible surgical stapler and firing to close tissueEndoscopic grasping forcepsPorcine nonsurvival39Meireles O.R. Kantsevoy S.V. Assumpcao L.R. et al.Reliable gastric closure after natural orifice translumenal endoscopic surgery (NOTES) using a novel automated flexible stapling device.Surg Endosc. 2008; 22: 1609-1613Crossref PubMed Scopus (50) Google Scholar and survival40Magno P. Giday S.A. Dray X. et al.A new stapler-based full-thickness transgastric access closure: results from an animal pilot trial.Endoscopy. 2007; 39: 876-880Crossref PubMed Scopus (78) Google Scholar Circular staplerPower MedicalAbsorbable mesh with interwoven endoloop is stapled into gastrostomy with cutting circular stapler. Defect closed by cinching endoloop.Laparoscopic assistance neededPorcine gastric explant, canine survival41Sherwinter D.A. Gupta A. Cummings L. et al.Evaluation of a modified circular stapler for use as a viscerotomy formation and closure device in natural orifice surgery.Surg Endosc. 2010; 24: 1456-1461Crossref PubMed Scopus (9) Google Scholar Suturing devicesLSI Solutions, Victor, NYPrototype device creating purse-string sutureNonePorcine gastric explant42Ryou M. Pai R.D. Sauer J.S. et al.Evaluating an optimal gastric closure method for transgastric surgery.Surg Endosc. 2007; 21: 677-680Crossref PubMed Scopus (80) Google ScholarEagle Claw flexible suturing deviceNonePorcine gastrotomy closure, survival43Chiu P.W. Lau J.Y. Ng E.K. et al.Closure of a gastrotomy after transgastric tubal ligation by using the Eagle Claw VII: a survival experiment in a porcine model (with video).Gastrointest Endosc. 2008; 68: 554-559Abstract Full Text Full Text PDF PubMed Scopus (71) Google Scholar Endoscopic rivetsN/A (prototype)Bioabsorbable polymer rivet with absorbable magnesium alloy needle tipNone mentionedExplanted stomachs44Hausmann U. Feussner H. Ahrens P. et al.Endoluminal endosurgery: rivet application in flexible endoscopy.Gastrointest Endosc. 2006; 64: 101-103Abstract Full Text Full Text PDF PubMed Scopus (26) Google ScholarOTSC, Over-the-scope clip; N/A, not available. Open table in a new tab TABLE 3Devices tested in humans (not currently marketed for endoscopic closure)DeviceCompanyBrief descriptionAssist devicesHuman studiesCommentsT anchorsEthicon Endo Surgery, Cincinatti, OhioT anchors cinched together in pairsEndoscopic grasping forceps as neededHas been used for closure of gastrogastric fistulae after Roux-en-Y gastric bypass45Spaun G.O. Martinec D.V. Kennedy T.J. et al.Endoscopic closure of gastrogastric fistulae by using a tissue apposition system (with videos).Gastrointest Endosc. 2010; 71: 606-611Abstract Full Text Full Text PDF PubMed Scopus (31) Google ScholarCase reports only, no long-term data availableNDO plicatorNDO Surgical, Mansfield, MassSingle-use, pledgeted, suture implantsTissue grasper, various guidewiresDesigned as an endoscopic therapy for GERD46von Renteln D. Schmidt A. Riecken B. et al.Gastric full-thickness suturing during EMR and for treatment of gastric-wall defects (with video).Gastrointest Endosc. 2008; 67: 738-744Abstract Full Text Full Text PDF PubMed Scopus (46) Google ScholarCase reports only, no long-term data availableG ProxUSGI Medical, San Clemente, CalifFlexible tissue grasper that can deliver expandable tissue anchorsTransport (shape-locking overtube)Gastric closure during transgastric cholecystectomy47Swanstrom L.L. Whiteford M. Khajanchee Y. Developing essential tools to enable transgastric surgery.Surg Endosc. 2008; 22: 600-604Crossref PubMed Scopus (93) Google Scholar, 48Sclabas G.M. Swain P. Swanstrom L.L. Endoluminal methods for gastrotomy closure in natural orifice transenteric surgery (NOTES).Surg Innov. 2006; 13: 23-30Crossref PubMed Scopus (140) Google ScholarAppears effective for gastrotomy closure in NOTESEndocinchBard, Murray Hill, NJEndoscopic suturing device intended for creating plications at GE junction to act as an antireflux procedureEndoscopic suturing deviceHas been used for closure of gastrogastric fistulae after Roux-en-Y gastric bypass49Fernandez-Esparrach G. Lautz D.B. Thompson C.C. Endoscopic repair of gastrogastric fistula after Roux-en-Y gastric bypass: a less-invasive approach.Surg Obes Relat Dis. 2010; 6: 282-288Abstract Full Text Full Text PDF PubMed Scopus (91) Google ScholarCase reports only, no long-term data availableNOTES, Natural orifice transluminal endoscopic surgery; GE, gastroesophageal. Open table in a new tab OTSC, Over-the-scope clip; N/A, not available. NOTES, Natural orifice transluminal endoscopic surgery; GE, gastroesophageal. Several case series have demonstrated successful use of the OTSC in the closure of acute GI perforations, anastomotic leaks, and chronic GI fistulae.6Kirschniak A. Kratt T. Stuker D. et al.A new endoscopic over-the-scope clip system for treatment of lesions and bleeding in the GI tract: first clinical experiences.Gastrointest Endosc. 2007; 66: 162-167Abstract Full Text Full Text PDF PubMed Scopus (262) Google Scholar, 9von Renteln D. Denzer U.W. Schachschal G. et al.Endoscopic closure of GI fistulae by using an over-the-scope clip (with videos).Gastrointest Endosc. 2010; 72: 1289-1296Abstract Full Text Full Text PDF PubMed Scopus (94) Google Scholar, 50Repici A. Arezzo A. De Caro G. et al.Clinical experience with a new endoscopic over-the-scope clip system for use in the GI tract.Dig Liver Dis. 2009; 41: 406-410Abstract Full Text Full Text PDF PubMed Scopus (83) Google Scholar, 51Iacopini F. Di Lorenzo N. Altorio F. et al.Over-the-scope clip closure of two chronic fistulas after gastric band penetration.World J Gastroenterol. 2010; 16: 1665-1669Crossref PubMed Scopus (50) Google Scholar, 52Parodi A. Repici A. Pedroni A. et al.Endoscopic management of GI perforations with a new over-the-scope clip device (with videos).Gastrointest Endosc. 2010; 72: 881-886Abstract Full Text Full Text PDF PubMed Scopus (148) Google Scholar, 53Pohl J. Borgulya M. Lorenz D. et al.Endoscopic closure of postoperative esophageal leaks with a novel over-the-scope clip system.Endoscopy. 2010; 42: 757-759Crossref PubMed Scopus (68) Google Scholar, 54Kirschniak A. Subotova N. Zieker D. et al.The Over-The-Scope Clip (OTSC) for the treatment of gastrointestinal ble