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

This study has been terminated.
(For business reasons)
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00394212
First received: October 27, 2006
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Obesity
Device: Transoral Suturing
Other: Sham Endoscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Weight Loss (%) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percent Weight Loss is computed as [(Baseline weight - 6 month weight) / Baseline weight] * 100


Secondary Outcome Measures:
  • Proportion of Subjects Achieving 15% Excess Weight Loss (EWL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    %Excess Weight Loss (%EWL) is computed as:[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100.

  • Proportion of Subjects Achieving Weight Stabilization at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Weight is stabilized if 6 month weight is +/- 2% from baseline weight.

  • Proportion of Subjects Achieving 20% Excess Weight Loss at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    %Excess Weight Loss (%EWL) is computed as: [(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100


Other Outcome Measures:
  • Weight Loss (%) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Data presentation based on Per Protocol Analysis with subjects analyzed on the basis of treatment performed and no imputation for missing data


Enrollment: 77
Study Start Date: November 2006
Study Completion Date: May 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00394212     History of Changes
Other Study ID Numbers: DVL-EC-002
Study First Received: October 27, 2006
Results First Received: August 3, 2011
Last Updated: October 8, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 18, 2014