Dilated Gastric Tissue
Conditions
Brief summary
Registry is designed to evaluate use of endolumenal tissue anchors for soft tissue approximation to repair a dilated gastric pouch and gastrojejunal anastomosis in post-Roux-En-Y gastric bypass patients presenting with weight regain. Registry will also assess tissue anchor durability.
Interventions
DEVICEendolumenal tissue approximation
Sponsors
USGI Medical
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Inclusion criteria
1. Patient is \> 18 years of age and \< 65 years of age 2. Patient is \> 2 yrs post-Roux-en-Y bypass surgery 3. Patient initially achieved \> 50% EWL after Roux-en-Y bypass surgery 4. Patient is a reasonable risk to undergo general anesthesia 5. Patient is able to provide written informed consent
Exclusion criteria
1. Patient has an esophageal stricture or other anatomy/condition that would preclude the use and passage of the endolumenal instruments 2. Physician determines another causal factor for weight regain other than stoma or pouch dilation 3. Patient is non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise
Countries
United States
Outcome results
None listed