N/A
N=24
Endoscopic Surgery for Bariatric Revision After Weight Loss Failure
Morbid Obesity · Weight Loss
Bottom Line
View on ClinicalTrials.gov: NCT01871896 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Aug 2023
Primary outcome: Primary: Mean Weight Loss — 13.3 Pounds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endoscopic Suturing to Create Early Satiety (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Weight Loss |
13.3 | — |
| SECONDARY Number of Participants With Resolved Co-morbidities |
23 | — |
| SECONDARY Tolerance |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Previous Roux-En-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG)
- Failure to lose >50% of their excess body weight after 1 year
- Failure of weight loss despite maximal medical therapy and medically-supervised diets
Exclusion Criteria
- Esophageal Stricture
- Marginal Ulcer at the gastrojejunostomy anastomosis
- Non-compliance with bariatric follow-up
- Gastric ulcers
- Paraesophageal hernias
Data sourced from ClinicalTrials.gov (NCT01871896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.