Dilated Gastric Tissue Clinical Trial
Official title:
Endolumenal Gastric Pouch and Gastrojejunal Anastomosis Reduction
| NCT number | NCT01003743 |
| Other study ID # | TP165 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | October 27, 2009 |
| Last updated | October 27, 2009 |
| Verified date | October 2009 |
| Source | USGI Medical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 19 Years to 64 Years |
| Eligibility |
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 |
N/A
| Country | Name | City | State |
|---|---|---|---|
| United States | University of California, San Diego | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| USGI Medical |
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