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.

• Procedure: Tissue plication
  Tissue apposition and plication of a dilated GJ anastomosis with the Endoscopic Suturing System
• Device: Endoscopic Suturing System
  Tissue plication of dilated GJ stoma
• Device: Tissue Plication
  Tissue plication for GJ stoma reduction

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.