Endolumenal Gastric Pouch and Gastrojejunal Anastomosis Reduction

NCT01003743 | Completed

• 1 other identifier: TP165
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dilated Gastric Tissue

Interventions

endolumenal tissue approximation DEVICE

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

• Patient is \> 18 years of age and \< 65 years of age
• Patient is \> 2 yrs post-Roux-en-Y bypass surgery
• Patient initially achieved \> 50% EWL after Roux-en-Y bypass surgery
• Patient is a reasonable risk to undergo general anesthesia
• Patient is able to provide written informed consent

You may not qualify if:

• Patient has an esophageal stricture or other anatomy/condition that would preclude the use and passage of the endolumenal instruments
• Physician determines another causal factor for weight regain other than stoma or pouch dilation
• Patient is non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise

Sponsors & Collaborators

• USGI Medical: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: October 29, 2009
• Last Updated: October 29, 2009

Record last verified: 2009-10

Locations

US (1)