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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 27, 2006
Last Updated Date	October 8, 2012
Start Date ^ICMJE	November 2006
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 8, 2012)	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
Original Primary Outcome Measures ^ICMJE (submitted: October 30, 2006)	Weight Loss
Change History	Complete list of historical versions of study NCT00394212 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 8, 2012)	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
Original Secondary Outcome Measures ^ICMJE (submitted: October 30, 2006)	Excess Weight Lost (EWL) Weight Stabilization Improvement in Comorbidities and Quality of Life Parameters
Current Other Outcome Measures ^ICMJE (submitted: October 8, 2012)	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
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
Official Title ^ICMJE	Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction (RESTORe) for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass Surgery
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Obesity
Intervention ^ICMJE	Device: Transoral Suturing suturing of anastomosis Other: Sham Endoscopy suturing not performed
Study Arm (s)	Experimental: 1 Transoral suturing of the dilated gastrojejunostomy Intervention: Device: Transoral Suturing Sham Comparator: 2 Sham Endoscopy (suturing not performed) Intervention: Other: Sham Endoscopy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	77
Completion Date	May 2009
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00394212
Other Study ID Numbers ^ICMJE	DVL-EC-002
Has Data Monitoring Committee	Yes
Responsible Party	C. R. Bard
Study Sponsor ^ICMJE	C. R. Bard
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	C. R. Bard
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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