Endolumenal Gastric Pouch and Gastrojejunal Anastomosis Reduction

Not Applicable

Completed

• Conditions: Dilated Gastric Tissue

• Registration Number: NCT01003743
• Lead Sponsor: USGI Medical

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-10
• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-27
• Last Update Submitted: 2009-10-27
• Study First Posted: 2009-10-29
• Last Update Posted: 2009-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 San Diego, California, United States