Endolumenal Gastric Pouch and Gastrojejunal Anastomosis Reduction

USGI Medical

Status: Completed

Conditions: Dilated Gastric Tissue

Treatments: Device: endolumenal tissue approximation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01003743

TP165

Details and patient eligibility

About

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.

Sex: All

Ages: 19 to 64 years old

Volunteers: No Healthy Volunteers

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