Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
Condition: Obesity
MeSH terms: Weight Loss
Intervention: Transoral Suturing; Sham Endoscopy
Intervention description: suturing of anastomosis; suturing not performed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Weight Loss; Transoral Suturing; Dilated gastrojejunostomy; Inadequate weight loss following primary RYGB

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.
    

Eligibility 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