Endoscopic Full-thickness Plication Research Articles

Effects of Endoscopic Full-Thickness Plication On GERD Measured By Multichannel Intraluminal Impedance Monitoring

Background: Endoscopic full-thickness plication (Plicator®) has been shown to be effective at controlling reflux symptoms and esophageal acid exposure in a recently published prospective randomized, sham-controlled trial. By means of multichannel intraluminal impedance monitoring (MII), detection of nonacid or weakly acidic reflux events, aerophagia, and differentiation of true reflux events from non-reflux events is possible. In this study, the effects of endoscopic full-thickness plication measured by MII was analysed. Patients and Methods: 11 patients requiring maintenance proton pump inhibitor therapy underwent endoscopic full-thickness plication for treatment of gastro-esophageal reflux disease (GERD). MII was performed off-medication before and 6 month after endoscopic full-thickness plication in all patients. The effect of endoscopic full-thickness plication on acid, nonacid and weakly acidic reflux events were assessed. Results: 11 patients underwent endoscopic full-thickness plication using two or three serially placed Plicator implants. The mean number of total reflux and acid reflux episodes significantly decreased after the procedure (123 vs. 63, p < 0.02, 75 vs. 37, p < 0.02. The mean acid exposure time significantly decreased after treatment (124 min. vs. 41 min., p < 0.01). Total reflux exposure time and the mean DeMeester score significantly decreased after treatment (9.2% vs. 2.9%, p < 0.01, 27 vs. 9, p < 0.01).). The mean number of non-acid reflux episodes were not significantly decreased after the procedure (48 vs. 26, p = 0.306). The median bolus clearance time was not significantly changed (12 sec. vs. 11 sec. p = 0.798). Conclusions: Evaluation of endoscopic full-thickness plication efficacy by MII showed significant reduction in the mean number of total reflux episodes, acid reflux episodes and total reflux exposure time. Furthermore, the mean DeMeester score and the mean total acid exposure time in the distal esophagus were significantly decreased. No significant decrease was measured for non-acid reflux episodes or the median bolus clearance time.

Endoscopic Full-Thickness Plication for GERD: 12-Month Multi-Center Study Results Using a Multiple Plication Technique

Background: The Plicator® (NDO Surgical, Mansfield MA) restructures the gastric cardia through endoscopic placement of a single transmural pledgeted suture at the gastroesophageal junction (GEJ). Although this procedure has been shown effective in the treatment of symptomatic GERD, the impact of placing multiple Plicator sutures in the gastric cardia has not previously been studied in a multi-center trial. In this study the safety and effectiveness of placing multiple full-thickness Plicator sutures in the gastric cardia in patients with symptomatic GERD was assessed. Patients & Methods: Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were entered into an open-label, prospective, multi-center trial. Study exclusions were hiatal hernia >3 cm, grade III and IV esophagitis, and Barrett's esophagus. Patients received two or more full-thickness Plicator sutures placed serially in the anterior gastric cardia, within 1 cm of the GEJ. Patients were evaluated at baseline and at 12-months post-treatment for GERD-HRQL score, VAS, and medication use. Esophagitis scores at baseline and at 6-months post-treatment were also evaluated. Primary treatment success was ≥50% improvement in GERD-HRQL score. Results: Forty-one patients underwent endoscopic full-thickness plication using multiple sutures as previously reported. Of the 35 patients who completed the 12-month follow-up, 74% had achieved ≥50% improvement in GERD-HRQL score. The median percent change in GERD-HRQL score improved significantly compared to baseline off-meds (77%, p < 0.001). Heartburn symptoms measured by VAS showed a median improvement of 81% versus baseline (p < 0.001). At baseline, all patients required daily PPI therapy. At 12-months post-treatment, 69% (24/35) of patients had discontinued daily PPI use and 71% were reportedly satisfied with the Plicator treatment. Sixty-nine percent (69%) also reported adequate control of both heartburn and regurgitation symptoms. At 6-months, the median esophagitis score was significantly improved by 75% (p = 0.005) compared to baseline. All procedure-related adverse events occurred acutely as previously reported and no new device-related adverse events were observed during the extended follow-up period. Conclusions: Multi-center study results demonstrate that endoscopic full-thickness plication using multiple transmural sutures is safe and effective in significantly reducing GERD symptoms, esophagitis scores and medication use.

Endoscopic Full-Thickness Plication for the Treatment of GERD: Five Year Multi-Center Results

Background: The Plicator® (NDO Surgical, Inc., Mansfield, MA) procedure, which is an endoscopic procedure that delivers a full-thickness plication, was previously reported to be effective at reducing GERD symptoms and medication use for up to 3-years post-plication with no long-term procedural adverse events. The purpose of this study was to assess the long-term safety and treatment durability of the Plicator up to 5-years post-plication. Methods: Patients with chronic heartburn who had originally participated in the open-label study and received a single plication in the gastric cardia 1 cm below the gastroesophageal junction were eligible. Subjects were evaluated at baseline for GERD symptoms and medication use. Long-term subject follow-up was completed to evaluate safety and long-term treatment durability. Results: Thirty-three subjects completed the long-term follow-up (mean follow-up interval: 5 years (59 months), range: 50-65 months). All procedure-related adverse events occurred acutely, as previously reported, and no new adverse events were observed during extended follow-up. At 5-years post-procedure, 67% of baseline PPI dependent patients remained off daily PPI therapy. Treatment effect remained stable from the 3 to 5-year follow-up interval, with 11/28 patients requiring daily PPI at 3-years compared to 12/30 patients at 5-years. Median GERD-HRQL scores remained significantly improved at 5-years versus baseline off-meds scores (10 vs. 19, p < 0.001). In addition, the proportion of patients achieving ≥ 50% improvement in GERD-HRQL score was consistent from 3-years (55%) to 5-years (50%). Conclusions: Endoscopic full-thickness plication can effectively reduce GERD symptoms and medication use for at least 5-years post-procedure. Treatment effect is stable for 5-years and there are no long-term procedural adverse effects.

Gastric full-thickness suturing following NOTES procedures for closure of the access site to the peritoneal cavity

Since the first publication on Natural Orifice Transluminal Endoscopic Surgery (NOTES) in 2004 research interest has grown steadily [1] [2]. It seems feasible that endoscopic surgery might be performed via a transgastric, transvaginal, or transcolonic route of access to the peritoneal cavity [2] [3] [4]. There is consensus on the criticality of a secure closure following NOTES procedures [2] [3] [4]. By means of endoscopic full-thickness plication (Plicator®, NDO Surgical, USA), expeditious and easy placement of transmural sutures can be facilitated [5].

Endoscopic full-thickness plication (Plicator) with two serially placed implants improves esophagitis and reduces PPI use and esophageal acid exposure

Recently, several endoluminal procedures for the treatment of gastroesophageal reflux disease (GERD) have been introduced. Most of these techniques have been abandoned because they lack long-term efficacy or have serious side effects. In a recently published prospective randomized, sham-controlled trial, the Plicator was shown to be effective at controlling reflux symptoms and esophageal acid exposure. In all previous studies, only a single implant was used. The aim of the present pilot study was to determine the safety and efficacy of two serially placed Plicator implants. Thirty-seven patients requiring maintenance therapy with proton pump inhibitors (PPIs) were enrolled in this single-center pilot study. All patients received two Plicator implants. Exclusion criteria were hiatus hernia larger than 3 cm, grade IV esophagitis, Barrett's esophagus, and esophageal motility disorders. The primary study end point was at least 50 % improvement in the GERD Health-Related Quality of Life (HRQL) score. Secondary end points included GERD medication use, esophageal acid exposure, esophagitis grade, and heartburn/regurgitation scores. Thirty-seven patients underwent endoscopic full-thickness plication using two serially placed Plicator implants. At 6 months after treatment, the proportion of patients achieving at least 50 % improvement in GERD-HRQL score was 68 %. Complete cessation of PPI treatment was achieved in 59 % of patients. In pH studies conducted at 6 months (n = 29), median percentage of time for which pH was below 4 decreased by 36 %, with 28 % of patients experiencing pH normalization. There were no serious adverse events requiring intervention. Endoscopic full-thickness plication using two serially placed Plicator implants was both safe and effective in reducing esophagitis, GERD symptoms, medication use, and esophageal acid exposure.

Gastric full-thickness suturing during EMR and for treatment of gastric-wall defects (with video)

The endoscopic full-thickness Plicator device was initially developed to provide an endoscopic treatment option for patients with GERD. Because the endoscopic full-thickness Plicator enables rapid and easy placement of transmural sutures, comparable with surgical sutures, we used the Plicator device for endoscopic treatment or prevention of GI-wall defects. To describe the outcomes and complications of endoscopic full-thickness suturing during EMR and for the treatment of gastric-wall defects. A report of 4 cases treated with the endoscopic full-thickness suturing between June 2006 and April 2007. A large tertiary-referral center. Four subjects received endoscopic full-thickness suturing. The subjects were women, with a mean age of 67 years. Of the 4 subjects, 3 received endoscopic full-thickness suturing during or after an EMR. One subject received endoscopic full-thickness suturing for treatment of a fistula. Primary outcome measurements were clinical procedural success and procedure-related adverse events. The mean time for endoscopic full-thickness suturing was 15 minutes. In all cases, GI-wall patency was restored or ensured, and no procedure-related complications occurred. All subjects responded well to endoscopic full-thickness suturing. The resection of one GI stromal tumor was incomplete. Because of the Plicator's 60F distal-end diameter, endoscopic full-thickness suturing could only be performed with the patient under midazolam and propofol sedation. The durable Plicator suture might compromise the endoscopic follow-up after EMR. The endoscopic full-thickness Plicator permits rapid and easy placement of transmural sutures and seems to be a safe and effective alternative to surgical intervention to restore GI-wall defects or to ensure GI-wall patency during EMR procedures.

Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial

Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial

Endoscopic full-thickness plication for the treatment of GERD: Five-year long-term multicenter results

The Plicator (NDO Surgical, Inc., Mansfield, MA) endoscopically places a full-thickness permanent suture to augment the antireflux barrier. At 3-years post-treatment, published results demonstrated a reduction in subjects' gastroesophageal reflux disease (GERD) symptoms and related medication use. To evaluate the Plicator's safety and durability of effect at improving GERD symptoms at 5-years post-treatment. A total of 33 chronic GERD sufferers across seven sites were followed for approximately 5 years (median follow-up: 59 months, range 50-65 months) after receiving a single full-thickness plication approximately 1 cm below the gastroesophageal (GE) junction in the anterior gastric cardia. At baseline, 30 out of 33 subjects required daily proton-pump inhibitor (PPI) therapy. Of the subjects who were PPI dependent prior to treatment 67% (20/30) remained off daily PPI therapy at 60 months and 5-year median GERD health-related quality-of-life (HRQL) scores show significant improvement from baseline off-meds scores (10 versus 19, p < 0.001). Additionally, 50% (16/32) of subjects achieved >or= 50% score improvement in GERD-HRQL. No new adverse events were identified and all device-related events occurred acutely. These results were comparable to the results seen at 36 months follow-up. Endoscopic full-thickness plication can reduce GERD symptoms and medication use for at least 5-years post procedure with no long-term adverse events post treatment.

Endoscopic Full-Thickness Plication with Two Serially Placed Implants Improves Esophagitis, GERD Symptoms and Reduces PPI Use and Esophageal Acid Exposure

Purpose: Recently, several endoluminal procedures for the treatment of GERD have been introduced. However, most of these techniques have been abandoned due to either lack of long-term efficacy or serious side effects. In a recently published prospective randomized, sham-controlled trial, the Plicator™ (NDO Surgical, Inc.) proved effective at controlling reflux symptoms and reducing medication use and esophageal acid exposure. Methods: In all studies to date, a single Plicator implant was placed to form a full thickness plication of the anterior gastric cardia. However, in several cases the narrowing of the GE-junction remained incomplete with this technique. Therefore, we evaluated the safety and effectiveness of placing two Plicator implants within 1 cm of the anterior GE-junction for the treatment of GERD. Results: 37 patients underwent endoscopic full-thickness plication using two serially placed Plicator implants. At 6 months post-treatment, the proportion of patients achieving >50% improvement in GERD-HRQL score was 68%. Complete PPI cessation was achieved in 59% of patients. In pH studies conducted at 6-months (N = 29), median percent time pH < 4 decreased 36%, with 28% of patients experiencing pH normalization. Erosive Reflux Disease (ERD) was diagnosed in 21 patients before endoscopic full-thickness plication. 16 patients had NERD before endoscopic full-thickness plication. Six months after endoscopic full-thickness plication the number of subjects with ERD was 15 and the number of subjects without esophagitis was 22. There were no serious adverse events observed. Minor adverse events included abdominal pain (73%), sore throat (54%), and chest pain (57%). All adverse events resolved spontaneously without intervention. Conclusion: In this study, endoscopic full-thickness plication using two serially placed Plicator implants was both safe and effective in reducing esophagitis, GERD symptoms, GERD medication use, and esophageal acid exposure. When compared to previous studies using a Plicator single implant technique, the Plicator multiple-implant technique demonstrates a similar safety profile and superior efficacy.

Endoscopic Full-Thickness Plication for the Treatment of GERD: Five Year Multi-Center Results

Purpose: We previously reported the Plicator (NDO Surgical, Inc., Mansfield, MA) procedure, which is an endoscopic procedure that delivers a full-thickness plication, to be effective at reducing GERD symptoms and medication use for up to 3-years post-plication with no long-term procedural adverse events. The purpose of this study was to assess the long-term safety and treatment durability of the Plicator up to 5-years post-plication. Methods: Subjects with chronic heartburn who had originally participated in the open-label study and received a single plication in the gastric cardia approximately 1 cm below the gastroesophageal junction were eligible. Subjects were evaluated at baseline for GERD symptoms and medication use. Long-term subject follow-up was completed to evaluate safety and long-term treatment durability. Results: Twenty-eight subjects completed the long-term follow-up (mean follow-up interval: 5 years (58 months), range: 50–65 months). All procedure-related adverse events occurred acutely, as previously reported, and no new adverse events were observed during extended follow-up. At 5-years post-procedure, 62% of baseline PPI-dependent patients remained off daily PPI therapy. Treatment effect remained stable from the 3 to 5-year follow-up interval, with 16/28 patients off daily PPI at 3-years compared to 15/24 patients at 5-years. Median GERD-HRQL scores remained significantly improved at 5-years versus baseline off-meds scores (10 vs. 19, P < 0.001). In addition, the proportion of patients achieving ≥ 50% improvement in GERD-HRQL score was consistent from 3-years (55%) to 5-years (50%). Conclusion: Endoscopic full-thickness plication can effectively reduce GERD symptoms and medication use for at least 5-years post-procedure. Treatment effect is stable for 5-years and there are no long-term procedural adverse effects.

Endoscopic Full-Thickness Plication for the Treatment of GERD: 12 Month Follow-Up in the Sham-Controlled Trial

Purpose: To evaluate the safety and efficacy of the NDO Plicator endoscopic procedure for the treatment of symptomatic GERD in a cohort of patients followed out to 12 months from their original participation in a sham-controlled study. Methods: Patients with chronic heartburn and pathologic reflux requiring daily proton pump inhibitor (PPI) therapy were enrolled. Excluded from treatment were patients with esophageal dysmotility, esophagitis grade III or IV (Savary-Miller), Barrett's epithelium, and hiatus hernia >2 cm. All patients received a single, endoscopically placed full-thickness plication in the anterior gastric cardia. The primary study endpoint was ≥50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included VAS, SF-36, GERD medication use, and esophageal acid exposure. Results: A total of 148 patients were treated at 14 study sites. No re-treatments were performed. Twelve-months post-plication, 59/96 patients (62%) had improved their GERD-HRQL score by at least 50%. Median percent change in GERD-HRQL score (62%), VAS score (46%), heartburn score (67%) and regurgitation score (50%) were all significantly improved compared to off meds baseline values. The need for daily PPI therapy was either eliminated or reduced by at least half in 63% of patients at 12-months post-treatment. There were no new or late onset adverse events. Conclusion: At 12-months post-procedure, the cohort originally treated with full-thickness plication with the Plicator and the cross-over group treated after sham showed the endoscopic treatment to be safe and effective in reducing GERD symptoms and medication use.

Endoscopic Full-Thickness Plication for the Treatment of GERD: 6 Month Data of the German Multi-Center Serial Implant Trial

Endoscopic Full-Thickness Plication for the Treatment of GERD: 6 Month Data of the German Multi-Center Serial Implant Trial

Endoscopic Full Thickness Plication in Patients with Hiatal Hernias Who Underwent Simultaneous Laparoscopic Closure of the Diaphragmatic Hiatus

Endoscopic Full Thickness Plication in Patients with Hiatal Hernias Who Underwent Simultaneous Laparoscopic Closure of the Diaphragmatic Hiatus

Endoscopic Full-Thickness Plication for GERD: 6-Month Follow-Up to a Multi-Center Sham-Controlled Trial

Background: The endoscopic full-thickness Plicator™ (NDO Surgical, Mansfield MA) delivers a transmural suture at the gastroesophageal junction to restructure the gastric cardia. The resulting tissue plication is intended to accentuate the valvular mechanism of the gastroesophageal junction. Aim: To evaluate the safety and efficacy of the Plicator procedure for the treatment of symptomatic GERD in a cohort of patients followed out from their original participation in a sham-controlled study. Methods: Patients with chronic heartburn and pathologic reflux requiring daily proton pump inhibitor (PPI) therapy were enrolled.

Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial

Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial

Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results

The purpose of the present study was to assess the long-term safety and durability of effect for endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux disease (GERD). The Plicator (NDO Surgical, Inc., Mansfield, MA) used delivers a transmural suture through the gastric cardia to restructure the antireflux barrier. Published reports have shown the Plicator procedure to be effective in reducing GERD symptoms and medication use at 1 year post-plication. Twenty-nine patients with chronic heartburn requiring maintenance daily anti-secretory therapy were treated at five sites. Patients received a single full-thickness plication in the gastric cardia 1cm below the gastroesophageal junction (GE) junction. Re-treatments were not permitted. Patients were evaluated at baseline for GERD symptoms and medication use. Intermediate (12 month) and long-term subject follow-up (median follow-up: 36.4 months; range, 31.2-43.9 months) were completed to evaluate procedure safety and durability of effect. Twenty-nine patients completed the 12-month and 36-month follow-up. All procedure-related adverse events occurred acutely, and no new events were observed during extended follow-up. At 36-months post-procedure, 57% (16/28) of baseline proton pump inhibitor (PPI)-dependent patients remained off daily PPI therapy. Treatment effect remained stable from 12- to 36-months, with 21/29 patients off daily PPI at 12 months compared to 17/29 patients at 36-months. Median GERD- Health Related Quality of Life (HRQL) scores remained significantly improved at 36 months versus baseline off-meds scores (8 versus 19, p < 0.001). In addition, the proportion of patients achieving > or = 50% improvement in GERD-HRQL score was consistent from 12 months (59%) to 36 months (55%). Endoscopic full-thickness plication can reduce GERD symptoms and medication use for at least 3-years post-procedure. Treatment effect is stable from 1 to 3 years, and there are no long-term procedural adverse effects.

Endoscopic full-thickness plication for the treatment of GERD: a randomized, sham-controlled trial

Background & aims: The aim of this study was to determine the effectiveness of endoscopic full-thickness plication (Plicator; NDO Surgical, Inc., Mansfield, MA) for the treatment of GERD in comparison to a sham procedure.

Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial

The aim of this study was to determine the effectiveness of endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease (GERD) in comparison with a sham procedure. Patients with symptomatic GERD requiring maintenance proton pump inhibitor (PPI) therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary end point was > or =50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included medication use and esophageal acid exposure. By intention-to-treat analysis, at 3 months, the proportion of patients achieving > or =50% improvement in GERD-HRQL score was significantly greater in the active group (56%) compared with the sham group (18.5%; P < .001). Complete cessation of PPI therapy was higher among patients in the active group than in the sham group by intention-to-treat analysis (50% vs 24%; P = .002). The percent reduction in median percent time pH < 4 was significantly improved within the active group versus baseline (7 vs 10, 18%, P < .001) but not in the sham group (10 vs 9, -3%, P = .686). Between-group analysis revealed the active therapy to be superior to the sham in improving median percent time pH < 4 (P = .010). There were no perforations or deaths. Endoscopic full-thickness plication more effectively reduces GERD symptoms, PPI use, and esophageal acid exposure than a sham procedure.

Endoscopic Full-Thickness Plication for GERD: 3 Month Follow-Up and 6 Month Interim Analysis in a Randomized, Sham-Controlled Trial

Endoscopic Full-Thickness Plication for GERD: 3 Month Follow-Up and 6 Month Interim Analysis in a Randomized, Sham-Controlled Trial

Endoscopic Full-thickness Plication for the Treatment of GERD: 12-month Follow-up for the North American Open-label Trial

Endoscopic Full-thickness Plication for the Treatment of GERD: 12-month Follow-up for the North American Open-label Trial