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

NCT00394212 | Terminated Phase 3 Results DMC

• 1 other identifier: DVL-EC-002
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Obesity

Keywords

Weight Loss; Transoral Suturing; Dilated gastrojejunostomy; Inadequate weight loss following primary RYGB

Outcome Measures

Primary Outcomes (1)

• Weight Loss (%)

  Percent Weight Loss is computed as \[(Baseline weight - 6 mo. weight) / Baseline weight\] \* 100

  6 months

Secondary Outcomes (3)

• Subjects Achieving 15% Excess Weight Loss (EWL)

  6 months

• Subjects Achieving Weight Stabilization at 6 Months

  6 months

• Subjects Achieving 20% Excess Weight Loss at 6 Months

  6 months

Study Arms (2)

1

EXPERIMENTAL

Transoral suturing of the dilated gastrojejunostomy

Device: Transoral Suturing

2

SHAM COMPARATOR

Sham Endoscopy (suturing not performed)

Other: Sham Endoscopy

Interventions

Transoral Suturing DEVICE

suturing of anastomosis

1

Sham Endoscopy OTHER

suturing not performed

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• months post primary RYGB with inadequate weight loss or weight regain
• BMI \>30 and ≤ 50
• Dilated gastrojejunal anastomosis
• Successfully completes screening process
• Signed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (10)

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Lebanon, New Hampshire, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Milwaukee, Wisconsin, United States

Location

Related Publications (1)

• Thompson CC, Chand B, Chen YK, DeMarco DC, Miller L, Schweitzer M, Rothstein RI, Lautz DB, Slattery J, Ryan MB, Brethauer S, Schauer P, Mitchell MC, Starpoli A, Haber GB, Catalano MF, Edmundowicz S, Fagnant AM, Kaplan LM, Roslin MS. Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Gastroenterology. 2013 Jul;145(1):129-137.e3. doi: 10.1053/j.gastro.2013.04.002. Epub 2013 Apr 5.

  PMID: 23567348 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Limitations and Caveats

Limitations of this study are that study enrollment was prematurely discontinued; therefore the study was underpowered for the analysis of both the primary and secondary effectiveness endpoints.

Results Point of Contact

• Title: Dawn Heimer, Clinical Research
• Organization: Davol Inc., Subsidiary of C.R. Bard

Dawn.Heimer@crbard.com

401-825-8681

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2006
• First Posted: October 31, 2006
• Study Start: November 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: May 1, 2009
• Last Updated: September 21, 2016
• Results First Posted: November 7, 2012

Record last verified: 2012-10

Locations

US (10)