StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight

Stopped early · Not applicable · Has a placebo group

Conditions studied: Obesity

In brief

The Roux-en-Y gastric bypass (RNYGB) is a weight loss surgery that involves the creation of a small gastric pouch and rearrangement of the small intestine. Although RNYGB has been demonstrated as an effective bariatric procedure, a significant number of patients experience weight regain that is often associated with distended gastric anatomy. Open and laparoscopic approaches for revision are associated with higher complication rates than de novo procedures. This study will evaluate the safety and effectiveness of a revisional incisionless natural orifice surgery of the gastric pouch and stoma in producing weight loss in post-RNYGB patients who have experienced weight regain.

Key facts

Study ID

NCT00939055

Run by

EndoGastric Solutions

People needed

112

Starts

2009-07-01

Expected to finish

2012-06-01

Last updated by the study team

2020-11-23

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age and less than 65 years of age
• BMI of at least 35 and no more than 40
• At least 2 years post-RNYGB surgery
• Initially achieved at least 60% EBL and a BMI 35 or less
• Regained at least 20% of pre-RNYGB excess weight at screening
• Stable weight or continued failure to lose weight for at least 3 months
• Enlarged gastric pouch (≥ 30 ml)
• Anatomy of upper GI judged suitable for revision using StomaphyX
• Completed successful nutritional screening
• Normal levels of vitamin D, iron/ferritin, calcium, and magnesium
• Absence of protein malnutrition confirmed by serum albumin > 3 g/dL
• Willing to cooperate with follow-up dietary recommendations and assessment tests
• Signed Informed Consent

You may not qualify if…

• Previous revisional bariatric surgery after RNYGB
• Esophageal stricture or any anatomic condition that precludes passage of the StomaphyX device to the gastric pouch
• Diabetes type I
• Causal factors for weight regain other than gastric pouch enlargement
• Serious complications experienced during and/or after RNYGB such as leaks, fistula, incisional hernia, ulcers, pulmonary embolism or deep venous thrombosis
• Pregnancy or plans of pregnancy in the next 12 months
• Immunosuppression
• ASA > 3
• Life expectancy less than one year
• An eating disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed, Washington DC, American Psychiatric Association, 2000
• Active substance abuse
• Plans of smoking cessation in the next 12 months
• Treatment with weight-loss prescription drug therapy within three months preceding the screening
• Intention to use prescription drug therapy or the use of over-the-counter weight-loss preparations during the current study
• Current participant in another weight-loss study or other clinical trial
• Inflammatory bowel disease
• Presence of ulceration at the gastrojejunostomy anastomosis
• Portal hypertension
• Coagulation disorders or chronic use of anticoagulants
• Any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk to the patient

Where it is running

• The Ohio State University Medical Center — Columbus, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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