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

June 29, 2007
September 8, 2009
February 2007
April 2008   (final data collection date for primary outcome measure)
Knotting Elements Placed [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00495222 on ClinicalTrials.gov Archive Site
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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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • 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
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
Interventions:
  • Procedure: Tissue plication
  • Device: Endoscopic Suturing System
  • Device: Tissue Plication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
June 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00495222
CI-06-0005
No
Susan Knippenberg, Ethicon Endo-Surgery
Ethicon Endo-Surgery
Not Provided
Principal Investigator: Alfonso Torquati, MD Vanderbilt University
Ethicon Endo-Surgery
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP