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

Sponsor:	C. R. Bard
Information provided by:	C. R. Bard
ClinicalTrials.gov Identifier:	NCT00394212

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	Phase III

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:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

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

Primary Outcome Measures:

Weight Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Excess Weight Lost (EWL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Weight Stabilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Improvement in Comorbidities and Quality of Life Parameters [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	129
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	Device: Transoral Suturing suturing of anastomosis
Sham Comparator: 2 suturing not performed	Device: Transoral Suturing suturing of anastomosis

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

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:	Tylea Furhmann, C. R. Bard
ClinicalTrials.gov Identifier:	NCT00394212 History of Changes
Other Study ID Numbers:	DVL-EC-002
Study First Received:	October 27, 2006
Last Updated:	May 16, 2011
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 February 12, 2012