Endolumenal Gastric Pouch and Gastrojejunal Anastomosis Reduction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Dilated Gastric Tissue

Interventions

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endolumenal tissue approximation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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University of California, San Diego

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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TP165

Identifier Type: -

Identifier Source: org_study_id