Ovesco Endoscopy AG Research Articles

OTSC Proctology clip as appropriate treatment for complicated anorectal fistula.

Evaluation of the effectiveness and tolerability of the application of an OTSC (Ovesco Endoscopy AG Tuebingen, Germany) Proctology clip as an innovative strategy of anorectal fistulae closure when established treatment strategies had already failed or were not feasible. Retrospective single-center study including consecutive patients treated between March 2014 and March 2016 with the OTSC Proctology system for anorectal fistula closure, including one rectovaginal and one rectourethral fistula. The primary outcome was the healing rate with a minimum follow up of 6 months. Healing was defined as closure of the internal fistula ostium and absence of secretion or local inflammation during follow up. A total of 66 fistula closures by the OTSC Proctology clip were investigated, including cryptoglandular fistulas (45/66 patients, 68%), fistulas associated with CED (19/66 patients, 29%), and other non-cryptoglandular fistulas (2/66 patients, 4%). 47% (31/66 patients) had a failed previous therapy. In that selected collective, a successful fistula closure was achieved in 29/66 cases (44%) after a median follow up time of 40 months (6-61 months). Suprasphincteric and high transsphincteric fistulas showed healing in 63% and 42% in CD associated fistulas. Fistula closure by the OTSC Proctology clip is an innovative, sphincter protecting treatment strategy in anorectal fistulas that can achieve long-term cure in complex anorecta.

Recent advances and current challenges in endoscopic resection with the full-thickness resection device.

Endoscopic full-thickness resection (EFTR) has emerged as a viable technique in the management of mucosal and subepithelial lesions of the gastrointestinal tract (GIT) not amenable to conventional therapeutic approaches. While various devices and techniques have been described for EFTR, a single, combined full-thickness resection and closure device (full-thickness resection device, FTRD system, Ovesco Endoscopy AG, Tuebingen, Germany) has become commercially available in recent years. Initially, the FTRD system was limited to use in the colorectum only. Recently, a modified version of the FTRD has been released for EFTR in the upper GIT as well. This review provides a broad summary of the FTRD, highlighting recent advances and current challenges.

Successful mucosal closure of artificial gastric ulcer with twin grasping forceps and endoclips after endoscopic submucosal dissection.

The risk of postoperative adverse events following endoscopic resection can be reduced through endoscopic closure of the artificial gastric ulcer [1], but it is not easy owing to the gastric wall thickness and hardness. There are several methods for closing ulcers induced by gastric endoscopic submucosal dissection (ESD) [2] [3] [4] [5]. Here, we describe the successful simple closure of a post-gastric ESD artificial ulcer using twin grasping forceps (Twin Grasper; Ovesco Endoscopy AG, Tubingen, Germany) and endoclips (EZ clip; Olympus, Tokyo, Japan).

Multimodal treatment of colorectal postsurgical leaks: long-term results of the over-the-scope clip (OTSC) application.

Postsurgical anastomotic colorectal leaks often require a surgical second look with a definite morbidity and the risk of delaying adjuvant treatment. The aim of this study was to analyse the long-term results of the endoscopic closure of colorectal leak following low anterior resection (LAR) using the over-the-scope (Ovesco™; Ovesco Endoscopy AG, Tübingen, Germany) clip. Patients who were submitted to endoscopic closure of a colorectal leak of maximum 2 cm with an Ovesco™ clip following LAR from 2016 to 2018 were enrolled in this retrospective single-center study (Humanitas Mater Domini Clinical Institute, Italy). The follow-up was obtained through radiologic and clinic assessments. In the analyzed study period, 48 patients were submitted to LAR. Six patients were enrolled in the study. The median diameter of the leak was 7 mm. 14/6t or 12/6t OTSC® clip was applied. Three patients were managed exclusively endoscopically, 2 of them had a protective ileostomy; 3 patients underwent urgent laparotomy with ostomy and then underwent endoscopic procedure. Complete healing was reached in all patients in a median of 23 days. Adjuvant chemotherapy was indicated and performed in 4 patients after a median of 64 days from the surgery. Among the 5 carriers of an ostomy, 4 patients underwent recanalization. The median follow-up was 21.5 months. During the follow-up no leak reoccurrence or complications were reported. In the multimodal management of anastomotic leaks following LAR, Ovesco™ clipping system appears a safe and effective technique in the closure of small leaks (<2 cm), allowing an early recanalization of the bowel and not delaying adjuvant chemotherapy when indicated.

Technical feasibility, clinical effectiveness, and safety of esophageal stricture dilation using a novel endoscopic attachment cap in adults with eosinophilic esophagitis

The BougieCap (Ovesco Endoscopy AG, Tübingen, Germany) is a new device that allows optical and tactile feedback during stricture dilation of the upper GI tract. We evaluated the technical feasibility, clinical efficacy, and safety of a 1-time esophageal stricture dilation using the BougieCap in adults with eosinophilic esophagitis (EoE). EoE patients prospectively included in the Swiss EoE Cohort were dilated with the BougieCap for esophageal strictures (esophageal diameter,≤14mm) and stricture-related symptoms. Symptoms were assessed before and 2 weeks after a single dilation session using the validated Eosinophilic Esophagitis Activity Index Patient Reported Outcomes instrument (score ranges from 0 to 100 points). Fifty patients (70% men; median age, 41 years; median disease duration, 4 years; 50% treated with swallowed topical corticosteroids, 10% with proton pump inhibitors, 14% with combined swallowed topical corticosteroids plus proton pump inhibitors, 14% with elimination diet, 12% without antieosinophil therapy) were evaluated. Endoscopic bougienage was technically successful in 100%. The median esophageal diameter increased from 12mm (interquartile range [IQR], 12-13) to 16mm (IQR, 16-16; P< .001). Median symptom severity dropped from 32 points (IQR, 27-41) to 0 (IQR, 0-10; P< .001) at 2 weeks postdilation. In 1 patient the BougieCap was temporarily lost after stricture dilation in the hypopharynx but could be retrieved. No severe adverse events were reported. In adults with EoE, endoscopic treatment of esophageal strictures using the BougieCap is technically feasible and safe and offers significant symptomatic improvement in the short term.

S2363 Underwater Full-Thickness Resection of a Colonic Polyp: A Novel Technique

INTRODUCTION: Underwater resection is an emerging technique in which the gastrointestinal lumen is distended with water instead of air, allowing the mucosal layer to float, facilitating lesion demarcation and resection. Underwater endoscopic mucosal resection (EMR) for colon polyps has been well-studied. Full-thickness resection device (FTRD, Ovesco Endoscopy AG, Tuebingen, Germany) is a dedicated system for single step full-thickness resection of colon lesions that are not amenable for resection by conventional methods. In this study, we combined both techniques to resect a recurrent adenomatous colonic polyp. CASE DESCRIPTION/METHODS: A 52-year-old female patient with no significant past medical history underwent screening colonoscopy which revealed a 2 cm polyp (Kudo IV) in the descending colon. The polyp was completely resected using underwater EMR. Histology report showed tubulovillous adenoma with low grade dysplasia. A follow-up colonoscopy was performed 3 months later and revealed a 2 cm sessile polyp at the previous resection site consistent with recurrent adenoma. Underwater full-thickness resection using FTRD was planned. A colonoscope was inserted and advanced to the lesion site. The FTRD grasper was used to grasp the lesion and pull it completely into the PRVE Cap. The lesion was determined to be amenable to full-thickness resection. The area surrounding the lesion was marked with the FTRD marking probe. The colon lumen was then distended with warm normal saline. The colonoscope was removed and the FTRD device was attached to the scope. The colonoscope with FTRD was then reinserted into the colon and advanced to the site of the lesion. The over-the-scope (OTS) clip was then deployed successfully and the FTRD snare was used to resect the lesion. The entire device and scope were withdrawn from the colon. A second colonoscope was then advanced into the colon to the site of resection with excellent visualization of the resected area. The resected lesion measured 2 cm × 2.5 cm. No complications were reported during or after the procedure. The patient was discharged on the same day. DISCUSSION: The use of FTRD in a water filled colon lumen can improve feasibility, efficacy, and safety of lesion resection via FTRD. Further research should be performed to determine whether the underwater technique enhances the FTRD procedure by possibly reducing procedure time and improving patient outcomes.

EUS-aided diagnosis and treatment of bleeding gastric Dieulafoy's lesion (with video).

Dieulafoy's lesion is an uncommon life-threatening condition, accounting for 1.5% of upper gastrointestinal (GI) bleeding.[1] This is due to tortuous arterioles (1–3 mm) seen in the submucosal layer,[2] also known as “persistent caliber arteries.” Usually, arteries narrow as they branch out toward the mucosa, and submucosal end arteries are normally 0.12–0.2 mm in diameter.[1] A 64-year-old diabetic and hypertensive male patient was being treated for chronic liver disease with portal hypertension. He underwent a transarterial chemoembolization procedure for hepatocellular carcinoma 2 years ago. He had a history of variceal band ligation. He was referred from a nearby general hospital where he presented with three episodes of hematemesis in the past 6 months. Endoscopy showed a vascular malformation (0.5 cm × 0.5 cm) with central ulcer in the fundus, with a small fundal vessel nearby [Figure 1a]. EUS showed a persistent caliber feeding arteriole with a diameter of 1.7 mm, suggestive of Dieulafoy's lesion, with a prominent vein nearby [Figure 2a]. Endoscopic hemoclipping was attempted, but hemostasis could not be attained because of the difficult position of the lesion. An Ovesco clip (OTSC®, Ovesco Endoscopy AG, Germany), which facilitates effective full circumferential tissue closure, including the vascular malformation, was used. Following deployment of the Ovesco clip, the Dieulafoy's lesion oozing was controlled, but there was separate new oozing from the vein nearby, which was possibly caused by one of the prongs of the Ovesco clip injuring the fundal vein. This was managed by injection of 0.5 ml of cyanoacrylate glue. Endoscopy repeated the following day showed the clip in situ with no active ooze [Figure 1b]. EUS after the procedure showed the clip at the Dieulafoy's lesion impeding flow in the artery [Figure 2b and Video 1]. The patient was under our follow-up for nearly 1 year without further episodes of GI bleeding. In our patient, the Ovesco clip was efficient in achieving hemostasis, as its design aids complete circumferential tissue closure including the vessel involved. There are few case reports for Ovesco clip use in Dieulafoy's in the stomach or duodenum.[34] Angiographic embolization and surgical interventions are reserved for cases when endoscopic interventions fail.Figure 1: (a) Endoscopic picture showing 5x5 mm sized vascular malformation with a small central ulcer (yellow arrow) with a small fundal vessel (white arrow) nearby. (b) Endoscopic picture showing Dieulafoy's lesion after OVESCO clipping (yellow arrow)Figure 2: (a) EUS showing a 1.7 mm sized persistent caliber artery in submucosa (pink arrow) with arterial Doppler pattern. (b) EUS showing OVESCO clip in situ (pink arrow) with abrupt cut off of the arteriole. Doppler suggests arterial patternDeclaration of patient consent The authors certify that they have obtained all appropriate patient consent forms. In the form the patient has given his consent for his images and other clinical information to be reported in the journal. The patient understands that his names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

1836 The Bougie Cap: A Novel Device for Treatment of Esophageal Strictures

INTRODUCTION: Treatment of high cervical esophageal strictures can be technically challenging. Placement of endoscopic balloons across the stricture may not be feasible due to their proximal location. Serial dilation with the use of Savary-Gilliard dilators is a well-established method for treatment of these strictures. However, this technique does not allow for direct optical feedback during dilation. We present a case of benign cervical esophageal stricture treated with a novel method utilizing the BougieCap (Ovesco Endoscopy AG). CASE DESCRIPTION/METHODS: A 62-year-old male presented with dysphagia. He had a prior history of peptic stricture at the gastroesophageal junction, treated with multiple balloon dilations that was complicated by an esophageal perforation. Patient underwent an emergent thoracotomy, esophagectomy, and gastric pull-up with placement of a feeding jejunostomy. Four months after surgery, he noted recurrence of dysphagia, with food getting lodged in the area below his throat and upper chest. Barium swallow revealed a tight stricture at the anastomosis that narrowed the lumen down to 5 mm in size. Upper endoscopy confirmed a stricture located 18 cm from the incisors. Using an endoscopic BougieCap the stricture was dilated serially from 7 to 12 mm in size with good results. Expected mucosal disruption was identified at the end of the procedure. On follow up, patient reported significant improvement in his symptoms without any complications. DISCUSSION: Use of Savary-Gilliard Dilators for stricture dilation provides only haptic control and often requires the use of fluoroscopic guidance. Our case highlights the use of a novel device - the BougieCap - for treatment of esophageal strictures which allows for direct visual control and optical feedback during the procedure. Ability to visualize the tension on the tissue while passing the stricture with the cap avoids overstretching and may help reduce the risk of complications, allowing for a more effective procedure. Moreover, by eliminating the need to switch instruments, the use of BougieCap can reduce procedure times. Additional prospective studies with a larger number of patients and long-term follow-up are necessary to determine its safety and long-term efficacy.

The BougieCap – a new method for endoscopic treatment of complex benign esophageal stenosis: results from a multicenter study

A major limitation of current treatment strategies for nonmalignant upper gastrointestinal stenoses is the lack of either optical or haptic feedback during dilation. Wire guidance and fluoroscopy is often necessary to control the position. A novel device for endoscopic dilation, the BougieCap (Ovesco Endoscopy AG, Tübingen, Germany) was evaluated in a prospective multicenter trial. Primary outcome was successful dilation of stenosis and secondary outcome was alteration in dysphagia symptoms in short-term follow-up. RESULTS: 50 patients with benign esophageal strictures were included. Endoscopic bougienage was successful in 96 %. Bougienage failed in two cases because of high resistance. Symptoms of dysphagia decreased significantly after bougienage (59.0 points at Day 0 vs. 28.6 points at Day 14; P < 0.001). Adverse events were loss of BougieCap into the stomach in two cases; no severe adverse events were reported. Endoscopic treatment of benign stenoses using the BougieCap enabled direct visual control of the bougienage procedure. This might help to adapt treatment more precisely to the stricture. Symptoms of dysphagia were improved in short-term follow-up. Additional wire guidance may be used for selected cases (e. g. narrow lumen, pediatric scope).

Novel telemetric sensor capsule for EGD urgency triage: a feasibility study.

Background and study aims Upper gastrointestinal bleeding (UGIB) is a frequent cause of hospitalization. Because of the lack of reliable noninvasive diagnostic tools, the decision to proceed with emergency endoscopy in these cases is made based on clinical parameters. A novel non-imaging telemetric real-time sensor capsule (HemoPill Acute, Ovesco Endoscopy AG) has shown promising results for noninvasive detection of UGIB in preclinical studies. Patients and methods We conducted a prospective non-randomized, single center, open-label study to investigate feasibility and safety of the novel sensor capsule in patients with symptoms of UGIB. The primary aim of the first clinical study was to investigate feasibility and safety of the device in a clinical setting. All patients underwent endoscopy within 12 hours after capsule ingestion. Sensor data from the capsule within 10 minutes after ingestion were compared with endoscopic findings. Results From April 2015 to February 2016, 30 consecutive patients with symptoms of acute UGIB were included; 27 were eligible for analysis. Capsule ingestion was well tolerated in all patients and there were no device-related adverse events. Endoscopy showed blood or hematin in the upper gastrointestinal tract of 10 of 27 patients; in 2 of 10 patients it was estimated to be more than 20 mL; in 4 of 8 patients it was between 5 and 20 mL and in 4 of 8 it was estimated to < 5 mL. The sensor capsule was positive in 2 of 2 patients (100 %) with > 20 mL of blood or hematin and in 1 of 8 patients (12.5 %) between 5 and 20 mL. All patients (17/17; 100 %) were correctly identified as non-bleeders. Conclusion Both device and procedure proved to be safe and feasible. Larger studies will be necessary to evaluate the role of the sensor capsule in risk stratification of patients with acute UGIB.

Performance of the over-the-scope clip system in the endoscopic closure of iatrogenic gastrointestinal perforations and post-surgical leaks and fistulas.

The increased invasiveness of endoscopic procedures and complex surgical interventions has resulted in an increased number of gastrointestinal iatrogenic defects, such as perforations, leak and fistulas. The conventional treatment for these gastrointestinal defects is surgery, with considerable risks especially in emergency situations and in patients with comorbidities. The Ovesco over-the-scope clip (OTSC) system (Ovesco Endoscopy AG, Tübingen, Germany) and more recently, the Padlock Clip™ (Aponos Medical, Kingston, NH, USA) have shown promising results in the treatment of gastrointestinal defects. Several case reports and case series have demonstrated the efficacy of the OTSC system for the closure of full-thickness defects. Clinical success is best achieved in patients undergoing closure of a perforation or a leak. Closure of fistulas remains a clinical challenge since fibrosis or necrotic and inflamed tissue surrounding lesions may cause clip failure. Over-the-scope clips are a less invasive endoscopic option for managing patients with gastrointestinal defects before a more invasive surgical approach is attempted. Moreover, a failed attempt of OTSC deployment does not preclude subsequent surgical treatment.

Efficacy and safety of the remOVE System for OTSC® and FTRD® clip removal: data from a PMCF analysis

Introduction: The remOVE System (Ovesco Endoscopy AG, Tuebingen, Germany) is a medical device for the endoscopic removal of OTSC or FTRD clips (Ovesco Endoscopy AG, Tuebingen, Germany). The aim of this paper is to assess the efficacy and safety of this system.Material and methods: A total of 74 patients underwent clip extraction. The standard removal procedure comprises fragmenting the clip by applying an electrical direct current pulse at two opposing sides of the clip.Results: Clip fragmentation was successful in 72 of 74 patients (97.3%). In two cases (2.7%) clip fragmentation was not possible. In nine cases (12.2%) a clip fragment could not be removed and was left in place. Complications occurred in three cases (4.1%): two minor bleedings near the clip removal site (2.7%), and one superficial mucosal tear resulting from clip fragment extraction (1.4%).Discussion: Based on this study, the use of the remOVE System for OTSC or FTRD clip removal can be considered safe and effective.

Over-the-scope clip-assisted endoscopic full-thickness resection of epithelial and subepithelial GI lesions

Endoscopic full-thickness resection (EFTR) allows for definitive diagnosis and treatment of select subepithelial and epithelial lesions unsuitable to conventional resection techniques. Our aim was to evaluate the efficacy and safety of over-the-scope (OTS) clip-assisted EFTR for these lesions. Patients who underwent OTS clip-assisted EFTR between June 2014 and October 2015 were analyzed. The procedure involved (1) thermal marking of the periphery of the lesion; (2) lesion suction into the cap of either an OTSC (Ovesco Endoscopy AG, Tübingen, Germany) or Padlock clip (Aponos Medical Corp, Kingston, NH, USA) with or without triprong anchor retraction of the lesion; (3) clip deployment; and (4) en bloc resection of the lesion above the clip using an electrosurgical snare and/or knife. Data were abstracted for demographics, lesion features, histopathologic diagnoses, R0 resection (negative margins) status, and adverse events. Nine patients (7 men) with a mean age of 63 ± 9.6 years were identified. The endoscopic findings included subepithelial lesions in the duodenum (n= 4), rectosigmoid colon (n= 2), stomach (n= 1), and postappendectomy appendiceal orifice polyps (n= 2). The mean lesion size was 8 ± 3mm and the mean procedure time 53 ± 21 minutes. R0 resection was confirmed in all cases. The histopathologic diagnoses included neuroendocrine tumors (n= 6), sessile serrated adenomas (n= 2), and pancreatic heterotopia (n=1). No adverse events were noted. OTS clip-assisted EFTR is an effective and safe technique for the removal of select subepithelial and epithelial lesions that are not amenable to conventional resection techniques.

Mo2054 Endoscopic Full-Thickness Resection With the Novel FTRD® System From OVESCO Endoscopy AG: Report on the First Dutch Experience

Mo2054 Endoscopic Full-Thickness Resection With the Novel FTRD® System From OVESCO Endoscopy AG: Report on the First Dutch Experience

Endoscopic Resection of a Diverticulum-Arisen Colonic Adenoma Using a Full-Thickness Resection Device

Endoscopic Resection of a Diverticulum-Arisen Colonic Adenoma Using a Full-Thickness Resection Device

Sa1387 A Randomised Trial Comparing Multiband Mucosectomy and ER-CAP for Endoscopic Piecemeal Resection of Early Squamous Neoplasia of the Esophagus

and evaluated using SPSS software. Patients’ symptom status were assessed using Velanovich gastroesophageal health related quality of life (GERD-HRQL) scores. The Chi-square and Mann Witney-U tests were used for statistical analysis. Results: Of the 16 (59.3%) male and 11 (40.7%) female patients, mean age was 39.6 (range: 24-60) years and mean body mass index was 26.2 kg/m2. Groups were similar as to gender, age, and body mass index. None of the LARS cases were converted to open surgery. The one esophageal perforation observed in the SRS group was completely resolved by over-the-scope clipping (OTSC Ovesco Endoscopy AG. Tubingen, Germany). The duration of procedures for SRS and LARS were 89 and 47 minutes, respectively (p 0.05). The mean discharge time was longer for the LARS group (1.2 days) than for the SRS group (3 days, p 0.05); however—excluding the complicated patient in SRS group who stayed for 21 days—length of hospital stay was almost identical in both groups: 1.1 and 1.2 days, respectively (p 0.05). During the 6 months mean follow-up, bloating and dysphagia rates were similar between the groups (p 0.05). Rate of postoperative PPI usage was insignificantly higher in the SRS group (27.3%) than in the LARS (6.3%) (p 0.05). The mean GERD HRQL scores dropped from 29.3 to 4.1 and 24.8 to 8.9 in LARS and SRS groups, respectively (p 0.05). Conclusions: The short term results of SRS are promising. New generations of SRS, soon to be undergoing trials, and increasing experience may further improve results and decrease the untoward effects.

806 Propensity Matched Analysis of Surgeon-Driven Treatment Allocation for Locoregionally Advanced Esophageal and Gastroesophageal Junction Adenocarcinoma

Introduction: There are few options available for treatment of fistulas, leaks, and perforations endoscopically. Here we describe our experience with a new endoscopic clipping system. Methods: A retrospective review of all cases using the Over-The-Scope-Clip system (Ovesco Endoscopy AG, Tuebingen, Germany) between August 2011 and November 2011. Resolution of leak was determined by a swallow study or CT scan. Results: The system was utilized in ten patients with clinically significant gastrointestinal surgical complications. Three patients were referred for treatment of gastric leaks following a sleeve gastrectomy, two had postoperative colonic leaks, two had gastro-gastric fistulas following roux-en-y gastric bypass, and three had esophageal perforations. All three gastric leaks occurred just distal to the GE junction and each had undergone previous attempts at treatment with other endoscopic methods. The average number of over the scope clips placed in these three patients was 2. In two patients there was complete resolution of the leak, one requiring a second clip placement. The third patient had a contained leak following clip placement that was followed clinically, follow up swallow study at six days showed improvement, and she was discharged home. Two patients had gastro-gastric fistulas following roux-en-y gastric bypass surgery. One of these patients had complete resolution of the fistula. The other had initial success but the clip displaced and fistula recurred. Two patients presented with anastomotic leak following colon resection. In one case the patient had extensive adhesions resulting in a rigid colon and the Ovesco system on a pediatric scope was too large to reach the fistula, so the procedure was aborted. In the second case, the leak was successfully treated with a single clip. Three patients were successfully treated for esophageal perforation. One had a 9 mm mid-esophageal perforation that required staged placement of two clips. One had two separate distal esophageal perforation sites, each requiring one clip. The final esophageal perforation was treated with a single clip. The average operative time for clip placement was 61 minutes. There were no complications. Conclusions: This over the scope endoscopic clip system is simple to use, safe, and successful in approximating tissue to treat traditionally difficult surgical complications. There is a potential for broad applications of this new technology. Further experience and longer follow up are needed to assess its indications as related to defect size and location.