CompletedNot Applicable

Endolumenal Gastric Pouch and Gastrojejunal Anastomosis Reduction

United States

Plain-language 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.

Who can participate

Age range19 Years – 64 Years

SexALL

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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

Trial details

NCT IDNCT01003743

SponsorUSGI Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Dilated Gastric Tissue trials