Status:
TERMINATED
StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight
Lead Sponsor:
EndoGastric Solutions
Conditions:
Obesity
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
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 e...
Detailed Description
The Roux-en-Y gastric bypass (RNYGB) is the most commonly performed bariatric procedure to treat morbid obesity 1. Numerous studies have documented the effectiveness of RNYGB in promoting excess weigh...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00939055
Start Date
July 1 2009
End Date
June 1 2012
Last Update
November 23 2020
Active Locations (2)
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1
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
2
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213