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

Tracking Information
First Received Date ^ICMJE	October 27, 2006
Last Updated Date	January 30, 2008
Start Date ^ICMJE	November 2006
Estimated Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 26, 2007)	Weight Loss [ Time Frame: 6 months ]
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 26, 2007)	Excess Weight Lost (EWL) [ Time Frame: 6 months ] Weight Stabilization [ Time Frame: 6 months ] Improvement in Comorbidities and Quality of Life Parameters [ Time Frame: 6 months ]
Original Secondary Outcome Measures ^ICMJE (submitted: October 30, 2006)	Excess Weight Lost (EWL) Weight Stabilization Improvement in Comorbidities and Quality of Life Parameters

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
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Obesity
Intervention ^ICMJE	Device: Transoral Suturing
Study Arms / Comparison Groups	Experimental: transoral suturing Sham Comparator: suturing not performed
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	230
Estimated Completion Date	March 2009
Estimated Primary Completion Date	January 2009 (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 ID ^ICMJE	NCT00394212
Responsible Party
Study ID Numbers ^ICMJE	DVL-EC-002
Study Sponsor ^ICMJE	C. R. Bard
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	C. R. Bard
Verification Date	January 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP