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Endoscopic Surgery for Bariatric Revision After Weight Loss Failure

NCT01871896 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-08-16

Study results available
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Summary

Morbid obesity and its associated metabolic diseases are on the rise in the United States. Currently, the best treatment for obesity is bariatric surgery where both roux-en-Y gastric bypass and sleeve gastrectomy offer substantial weight loss. Unfortunately, 20% of patients who undergo bariatric surgery fail to lose enough weight defined as less than 50% of excess body weight loss or regain of weight. For those patients who fail to lose weight after bariatric surgery and have failed maximal medical therapy and diet supervision, the treatment is re-operation and revision. Re-operation of the abdomen carries significant postoperative morbidity and mortality. The investigators propose to use the Apollo OverStitch endoscopic suturing device that has already been approved by the FDA as an option for bariatric surgery revision without having to re-operate on the patient. The investigators believe that the endoscopic technique may be able to provide weight loss without having to re-operate on the patient.

Conditions

Interventions

DEVICE

Endoscopic Suturing to Create Early Satiety

Evaluating the efficacy of endoscopic suturing for weight loss.

Sponsors & Collaborators

Principal Investigators

  • Stanley J Rogers, MD · University of California, San Francisco

  • Jonathan T Carter, MD · University of California, San Francisco

  • John P Cello, MD · University of California, San Francisco

  • Matthew Lin, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01871896 on ClinicalTrials.gov