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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00394212
• Date of registration: 27/10/2006
• Primary sponsor: C. R. Bard
• Public title: Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
• Scientific 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
• Date of first enrolment: November 2006
• Target sample size: 129
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00394212
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Obesity

Intervention(s)

Device: Transoral Suturing

Primary Outcome(s)

Weight Loss [Time Frame: 6 months]

Secondary Outcome(s)

Excess Weight Lost (EWL) [Time Frame: 6 months]

Improvement in Comorbidities and Quality of Life Parameters [Time Frame: 6 months]

Weight Stabilization [Time Frame: 6 months]

Secondary ID(s)

DVL-EC-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors