Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
Primary Purpose
Obesity
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Transoral Suturing
Sham Endoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Weight Loss, Transoral Suturing, Dilated gastrojejunostomy, Inadequate weight loss following primary RYGB
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
1
2
Arm Description
Transoral suturing of the dilated gastrojejunostomy
Sham Endoscopy (suturing not performed)
Outcomes
Primary Outcome Measures
Weight Loss (%)
Percent Weight Loss is computed as [(Baseline weight - 6 mo. weight) / Baseline weight] * 100
Secondary Outcome Measures
Subjects Achieving 15% Excess Weight Loss (EWL)
%Excess Weight Loss (%EWL) is computed as:[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100.
Subjects Achieving Weight Stabilization at 6 Months
Weight is stabilized if 6 month weight is +/- 2% from baseline weight.
Subjects Achieving 20% Excess Weight Loss at 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00394212
Brief Title
Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
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 Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
For business reasons
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight Loss, Transoral Suturing, Dilated gastrojejunostomy, Inadequate weight loss following primary RYGB
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Transoral suturing of the dilated gastrojejunostomy
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Sham Endoscopy (suturing not performed)
Intervention Type
Device
Intervention Name(s)
Transoral Suturing
Intervention Description
suturing of anastomosis
Intervention Type
Other
Intervention Name(s)
Sham Endoscopy
Intervention Description
suturing not performed
Primary Outcome Measure Information:
Title
Weight Loss (%)
Description
Percent Weight Loss is computed as [(Baseline weight - 6 mo. weight) / Baseline weight] * 100
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Subjects Achieving 15% Excess Weight Loss (EWL)
Description
%Excess Weight Loss (%EWL) is computed as:[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100.
Time Frame
6 months
Title
Subjects Achieving Weight Stabilization at 6 Months
Description
Weight is stabilized if 6 month weight is +/- 2% from baseline weight.
Time Frame
6 months
Title
Subjects Achieving 20% Excess Weight Loss at 6 Months
Description
%Excess Weight Loss (%EWL) is computed as: [(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Denver
State/Province
Colorado
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Lebanon
State/Province
New Hampshire
Country
United States
City
New York
State/Province
New York
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23567348
Citation
Thompson CC, Chand B, Chen YK, DeMarco DC, Miller L, Schweitzer M, Rothstein RI, Lautz DB, Slattery J, Ryan MB, Brethauer S, Schauer P, Mitchell MC, Starpoli A, Haber GB, Catalano MF, Edmundowicz S, Fagnant AM, Kaplan LM, Roslin MS. Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Gastroenterology. 2013 Jul;145(1):129-137.e3. doi: 10.1053/j.gastro.2013.04.002. Epub 2013 Apr 5.
Results Reference
derived
Learn more about this trial
Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
We'll reach out to this number within 24 hrs