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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00394212
• Other study ID #: DVL-EC-002
• Status: Terminated
• Phase: Phase 3
• First received: October 27, 2006
• Last updated: October 8, 2012
• Start date: November 2006
• Est. completion date: May 2009

Study information

• Verified date: October 2012
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: May 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Device:
• Transoral Suturing
suturing of anastomosis

Other:
• Sham Endoscopy
suturing not performed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight Loss (%)	Data presentation based on Per Protocol Analysis with subjects analyzed on the basis of treatment performed and no imputation for missing data	6 months	No
Primary	Weight Loss (%)	Percent Weight Loss is computed as [(Baseline weight - 6 month weight) / Baseline weight] * 100	6 months	No
Secondary	Proportion of 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.	6 months	No
Secondary	Proportion of Subjects Achieving Weight Stabilization at 6 Months	Weight is stabilized if 6 month weight is +/- 2% from baseline weight.	6 months	No
Secondary	Proportion of 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	6 months	No