University of California, San Diego
San Diego, California, 92103, United States
Completed
NCT Number: NCT01003743
Endolumenal Gastric Pouch and Gastrojejunal Anastomosis Reduction
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.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
19 year–64 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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
Treatment and study plan
endolumenal tissue approximation
DeviceSponsors and collaborators
Lead sponsor
USGI Medical
Industry
Registry information
Important dates
- First posted
- Oct 29, 2009
- Registry last updated
- Oct 29, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.