N/A
Completed N=9
Endoscopic Suturing System for Tissue Apposition
Source: ClinicalTrials.gov NCT00495222 ↗Enrolled (actual)
9
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Knotting Elements Placed — 11 elements
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knotting Elements Placed |
11 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00495222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.