Endoscopic Suturing System for Tissue Apposition

Evaluation of an Endoscopic Suturing System for Tissue Apposition

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.

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.