Endoscopic Suturing System for Tissue Apposition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00495222
Recruitment Status : Completed
First Posted : July 3, 2007
Results First Posted : August 11, 2009
Last Update Posted : September 10, 2009
Information provided by:
Ethicon Endo-Surgery

June 29, 2007
July 3, 2007
April 21, 2009
August 11, 2009
September 10, 2009
February 2007
April 2008   (Final data collection date for primary outcome measure)
Knotting Elements Placed [ Time Frame: intra-operative ]
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Complete list of historical versions of study NCT00495222 on 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.

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Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
  • Procedure: Tissue plication
  • Device: Endoscopic Suturing System
  • Device: Tissue Plication
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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.
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Susan Knippenberg, Ethicon Endo-Surgery
Ethicon Endo-Surgery
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Principal Investigator: Alfonso Torquati, MD Vanderbilt University Medical Center
Ethicon Endo-Surgery
September 2009

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