Condition(s) treated: Weight Loss

Intervention: Transoral Suturing (Device)

Phase: Phase 3

Enrollment status: Recruiting. Expecting to enroll 220 people.

Sponsor: C. R. Bard

As a result of the continued rise of obesity rates, bariatric procedures have become the fastest growing surgical procedures in the United States. The RYGB remains the most commonly performed procedure. Although numerous studies have documented the effectiveness of this procedure, some patients fail to lose sufficient weight or regain weight over time. One possible mechanism for inadequate weight loss or weight regain is the dilatation of the gastrojejunal anastomosis leading to decreased distention of the pouch and diminished satiety response. Treatment options for these patients are limited. Surgical revisions with the goal of achieving weight loss have a greater morbidity than primary RYGB and their success in controversial, underscoring the need for a less invasive alternative. This clinical investigation is a prospective, multi-center, randomized, blinded, two-arm study to evaluate weight loss and other clinical outcomes following application of transoral reduction of a dilated gastrojejunostomy (DGJ) anastomosis in participants who have inadequate weight loss following Roux-en-Y gastric bypass.

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

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Weight Loss

Secondary outcome: Excess Weight Lost (EWL); Weight Stabilization; Improvement in Comorbidities and Quality of Life Parameters

Minimum eligible age: 18 Years. Eligible gender(s): Both.

Criteria:

Inclusion Criteria:

- 6 months post primary RYGB with inadequate weight loss

- BMI >30 and ≤ 50

- Dilated gastrojejunal anastomosis

- Successfully completes screening process

- Signed consent

Exclusion Criteria:

- Recent tobacco cessation

- 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 < 1year

- 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.

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Not yet recruiting
Christopher C Thompson, MD, Phone: 617-732-6389, Email: ccthompson@partners.org
Christopher C Thompson, MD, Principal Investigator

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Recruiting
Rich Rothstein, MD, Email: richard.rothstein@dartmouth.edu
Rich Rothstein, MD, Principal Investigator

Lenox Hill Hospital, New York, New York 10022, United States; Not yet recruiting
Mitchell S Roslin, MD, Phone: 212-434-3285, Email: MRoslin@LENOXHILL.NET
Mitchell S Roslin, MD, Principal Investigator

Start date: November 2006
End date: October 2008
Last updated: October 30, 2006