Endoscopic Sleeve Gastroplasty for Obesity
Trial Summary
What is the purpose of this trial?
This trial is studying the safety and effectiveness of a procedure called Endoscopic Sleeve Gastroplasty (ESG) for weight loss in obese patients with ulcerative colitis who are having their colon removed. ESG makes the stomach smaller, helping patients eat less and lose weight. The study compares ESG to diet and lifestyle counseling.
Will I have to stop taking my current medications?
The trial requires that you avoid using weight loss medications, supplements, or herbal preparations. If you are using corticosteroids at a dose greater than 5 mg daily or anti-inflammatory agents like non-steroidal medications or anticoagulants, you must be under medical supervision. The protocol does not specify other medication restrictions.
What data supports the effectiveness of the treatment Endoscopic Sleeve Gastroplasty for Obesity?
Is Endoscopic Sleeve Gastroplasty safe for humans?
How is the Endoscopic Sleeve Gastroplasty treatment different from other obesity treatments?
Endoscopic Sleeve Gastroplasty (ESG) is unique because it is a minimally invasive procedure that uses an endoscopic suturing device to reduce the size of the stomach, helping patients lose weight without the need for traditional surgery. This makes it a less complex and potentially safer option for those who cannot undergo or prefer to avoid conventional obesity surgeries.12357
Research Team
Amanda M Johnson, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for obese ulcerative colitis patients planning or having had colectomy, aiming for ileal pouch anal anastomosis. They must have a BMI between 30-50 kg/m2, be willing to follow diet and lifestyle changes, attend scheduled visits, and provide consent. Women should use birth control if of childbearing potential.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Endoscopic Sleeve Gastroplasty (ESG) Procedure
Participants undergo Endoscopic Sleeve Gastroplasty (ESG) followed by a 6-week transitional diet
Lifestyle Intervention
Participants start a lifestyle intervention following the transitional diet
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of peri-operative complications and weight loss
Treatment Details
Interventions
- Apollo Endoscopic Suture System (Endoscopic Sleeve Gastroplasty)
- Lifestyle Intervention (Behavioral Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor