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Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass

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.
ClinicalTrials.gov Identifier: NCT00394212
Recruitment Status : Terminated (For business reasons)
First Posted : October 31, 2006
Results First Posted : November 7, 2012
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost. One possible explanation is that the opening between the stomach pouch and the intestine becomes stretched. If this opening becomes too wide, food may be able to pass from the stomach to the intestine too quickly - causing patients to feel less full after eating.

For some patients, doctors may recommend additional invasive surgery to tighten the opening between the stomach pouch and the small intestine. Although this may help patients resume their weight loss, the risk of complications during a second surgical procedure is significantly higher than the risk during the original gastric bypass.

The purpose of this study is to evaluate an incisionless procedure for patients who have either had inadequate weight loss or have regained weight following gastric bypass. The procedure is designed to tighten the opening between the stomach pouch and the small intestine, which may slow down the passage of food to help patients feel full longer after eating.


Condition or disease Intervention/treatment Phase
Obesity Device: Transoral Suturing Other: Sham Endoscopy Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction (RESTORe) for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass Surgery
Study Start Date : November 2006
Primary Completion Date : September 2008
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Transoral suturing of the dilated gastrojejunostomy
Device: Transoral Suturing
suturing of anastomosis
Sham Comparator: 2
Sham Endoscopy (suturing not performed)
Other: Sham Endoscopy
suturing not performed


Outcome Measures

Primary Outcome Measures :
  1. Weight Loss (%) [ Time Frame: 6 months ]
    Percent Weight Loss is computed as [(Baseline weight - 6 mo. weight) / Baseline weight] * 100


Secondary Outcome Measures :
  1. Subjects Achieving 15% Excess Weight Loss (EWL) [ Time Frame: 6 months ]
    %Excess Weight Loss (%EWL) is computed as:[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100.

  2. Subjects Achieving Weight Stabilization at 6 Months [ Time Frame: 6 months ]
    Weight is stabilized if 6 month weight is +/- 2% from baseline weight.

  3. Subjects Achieving 20% Excess Weight Loss at 6 Months [ Time Frame: 6 months ]
    %Excess Weight Loss (%EWL) is computed as: [(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 months post primary RYGB with inadequate weight loss or weight regain
  • BMI >30 and ≤ 50
  • Dilated gastrojejunal anastomosis
  • Successfully completes screening process
  • Signed consent

Exclusion Criteria:

  • Recently quit smoking or plan to quit within the next year
  • Pregnant or planning to become pregnant over the course of the next 9 months
  • Mallampati score of 4
  • Serious systemic disease or active disease of the gastrointestinal tract
  • Gastric pouch abnormalities
  • Significant movement limitations
  • Use of weight-promoting or weight-reduction drugs during study period
  • Severe eating disorders
  • Uncontrolled depression or psychoses
  • Ongoing severe complication resulting from initial RYGB or other condition that in the investigators' assessment would make the patient an unsuitable candidate for the study procedure
  • History of significant cardiovascular, cerebrovascular or pulmonary disease
  • Not a candidate for conscious or general sedation
  • Anticoagulant therapies
  • Active substance abuse
  • Life expectancy < 1 year
  • Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trial's study endpoints
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394212


Locations
United States, Colorado
Denver, Colorado, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New York
New York, New York, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
C. R. Bard
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00394212     History of Changes
Other Study ID Numbers: DVL-EC-002
First Posted: October 31, 2006    Key Record Dates
Results First Posted: November 7, 2012
Last Update Posted: September 21, 2016
Last Verified: October 2012

Keywords provided by C. R. Bard:
Weight Loss
Transoral Suturing
Dilated gastrojejunostomy
Inadequate weight loss following primary RYGB

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms