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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

October 27, 2006
October 8, 2012
November 2006
September 2008   (final data collection date for primary outcome measure)
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
Weight Loss
Complete list of historical versions of study NCT00394212 on ClinicalTrials.gov Archive Site
  • 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
  • Excess Weight Lost (EWL)
  • Weight Stabilization
  • Improvement in Comorbidities and Quality of Life Parameters
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
Not Provided
 
Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction (RESTORe) for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass Surgery

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • Device: Transoral Suturing
    suturing of anastomosis
  • Other: Sham Endoscopy
    suturing not performed
  • Experimental: 1
    Transoral suturing of the dilated gastrojejunostomy
    Intervention: Device: Transoral Suturing
  • Sham Comparator: 2
    Sham Endoscopy (suturing not performed)
    Intervention: Other: Sham Endoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
77
May 2009
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00394212
DVL-EC-002
Yes
C. R. Bard
C. R. Bard
Not Provided
Not Provided
C. R. Bard
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP