Endoscopic Suturing System for Tissue Apposition

Study Overview
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Brief Summary
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The objective of this feasibility trial is to evaluate the Ethicon Endo-Surgery Endoscopic Suturing System (ESS) for tissue apposition and reduction of the size of a dilated GJ anastomosis in subjects who are regaining weight after successful weight loss following gastric bypass. Post-procedure weight will be followed to assess whether weight loss is resumed. The ESS is an FDA-cleared (510(k)) sterile, single-use, disposable suturing system indicated for endoscopic placement of suture(s) and approximation of soft tissues. It is designed to facilitate endoscopic gastrointestinal procedures.

Official Title
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Evaluation of an Endoscopic Suturing System for Tissue Apposition

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Tissue plication
* Device: Endoscopic Suturing System
* Device: Tissue Plication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects must fulfill the following criteria to be entered in this study: Review and sign informed consent; Between 21 and 65 years of age (inclusive) at time of trial enrollment; Documented Roux-en-Y Gastric Bypass (RYGB) surgery date Documented baseline weight at the time of RYGB procedure; > 12 months post RYGB); Body mass Index (BMI) > 30 and at least 20 pounds in excess of post-RYGB weight nadir; Patients initially achieved at least 50% excess weight loss (EWL) post RYGB; Visible anastomotic junction (between gastric pouch and the Roux-limb); Stoma size at screening > 15mm; and Negative serum pregnancy test for women of childbearing potential. Exclusion Criteria Subjects will be excluded from the trial for any of the following: Documented history of esophageal pathology (e.g., esophageal varices, Barrett's Esophagus); American Anesthesia Association (ASA) Class IV or V and/or any contraindications to monitored anesthesia; Documented history of GJ anastomosis stricture (within 6 months); Documented history of previous RYGB revision; Presence or documented presence of gastric/duodenal ulcers; Presence of sepsis; Medical or physical endoscopic contraindications, including esophageal varices or bleeding, laryngeal perforation, trauma to pharynx, aspiration pneumonia, acute peritonitis, and other conditions where general endoscopic techniques and/or placement of overtube are contraindicated; Chronic Non-Steroidal Anti-Inflammatory Drug (NSAID) use (subjects taking a single aspirin tablet per day for cardioprotection are considered acceptable); Uncontrolled diabetes; Physical or psychological condition which would impair trial participation per investigator discretion; Binge-eating or similar eating disorders; Unable or unwilling to attend follow-up visits and examinations; Concurrent surgical procedure (intra-operative exclusion during ESS procedure); Participation in any other investigational device or drug trial within 30 days prior to enrollment; or Any condition, which precludes compliance with the trial.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tissue plication<br>The Endoscopic Suturing System (ESS) is used for tissue apposition and reduction of the size of a dilated GJ anastomosis in subjects who are regaining weight after successful weight loss following gastric bypass | Procedure: Tissue plication<br>* Tissue apposition and plication of a dilated GJ anastomosis with the Endoscopic Suturing System<br>Device: Endoscopic Suturing System<br>* Tissue plication of dilated GJ stoma<br>Device: Tissue Plication<br>* Tissue plication for GJ stoma reduction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knotting Elements Placed | completion of plication (1-3 knotting elements placed per procedure) | intra-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stoma, gastrojejunostomy