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Endoscopic Suturing System for Tissue Apposition

This study has been completed.
Sponsor:
Information provided by:
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00495222
First received: June 29, 2007
Last updated: September 8, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Procedure: Tissue plication
Device: Endoscopic Suturing System
Device: Tissue Plication

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of an Endoscopic Suturing System for Tissue Apposition

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Knotting Elements Placed [ Time Frame: intra-operative ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: February 2007
Study Completion Date: June 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tissue plication
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
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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495222

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Ethicon Endo-Surgery
Investigators
Principal Investigator: Alfonso Torquati, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Susan Knippenberg, Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00495222     History of Changes
Other Study ID Numbers: CI-06-0005
Study First Received: June 29, 2007
Results First Received: April 21, 2009
Last Updated: September 8, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Ethicon Endo-Surgery:
gastrojejunostomy
stoma

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013