Obesity
Conditions
Brief summary
The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in the United States. Despite initial weight loss, some patients experience weight regain that may be related to an increase in the size of the gastric pouch and/or stoma. A second surgical procedure to reduce the size of the pouch and/or stoma is typically associated with a higher risk of death or complications than the original gastric bypass procedure. This study will evaluate a less invasive, endolumenal alternative to pouch and stoma revision as a means of producing weight loss in patients who have regained weight following gastric bypass.
Interventions
PROCEDUREendolumenal surgery
Sponsors
USGI Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 18 yrs of age or older and \< 65 yrs of age * At least 2 yrs post-Roux-En-Y gastric bypass surgery * Initially achieved at least 50% weight loss * At enrollment, has regain at least 15% of weight loss * BMI 40 or greater or 35 or greater with one or more co-morbidities * Stoma diameter at least 20 mm * Completes successful nutritional screening * Is a candidate for a surgical revision procedure * Is a reasonable risk to undergo general anesthesia * Completes successful cardiopulmonary evaluation * ASA Classification of less than or equal to III * Able to provide written consent * Able to return for protocol-specified evaluations
Exclusion criteria
* Esophageal stricture or other anatomy/condition that precludes passage of endolumenal instruments * Previous bariatric revision procedure * Has another causal factor for weight regain other than stoma or pouch dilatation * Non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise program
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight loss | — |
Countries
United States
Outcome results
None listed