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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 09, 2014