Endoscopic Sleeve Gastroplasty for Weight Loss in Obese Patients with Ulcerative Colitis
Endoscopic Sleeve Gastroplasty (ESG) as a Treatment Option for Obesity in Ulcerative Colitis (UC) Patients Undergoing Colectomy With Ileal Pouch Anal Anastomosis (IPAA)
NA · Mayo Clinic · NCT05739162
This study is testing if a new weight loss procedure called Endoscopic Sleeve Gastroplasty can help obese patients with Ulcerative Colitis manage their weight better before surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 22 Years to 69 Years |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05739162 on ClinicalTrials.gov |
What this trial studies
This research investigates the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) as a weight loss intervention for obese patients diagnosed with Ulcerative Colitis (UC) who are undergoing colectomy. The study aims to gather data on how ESG can assist in weight management for this specific population, particularly those planning for an ileal pouch anal anastomosis (IPAA). Participants will receive the Apollo Endoscopic Suture System treatment along with lifestyle interventions to support their weight loss journey.
Who should consider this trial
Good fit: Ideal candidates include individuals with a BMI of 30-50 kg/m2 who have been diagnosed with Ulcerative Colitis and are planning to undergo or have already undergone colectomy.
Not a fit: Patients who have had prior gastric or bariatric surgery or those with significant gastrointestinal complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new weight loss option for obese patients with Ulcerative Colitis, improving their overall health and surgical outcomes.
How similar studies have performed: While ESG is a relatively novel approach for this specific patient population, similar studies have shown promise in using ESG for weight loss in other groups.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI 30-50 kg/m2 for at least 6 months prior to ESG * Diagnosis of UC with plans to undergo or who have already undergone colectomy as part of a plan to pursue eventual 3-stage ileal pouch anal anastomosis (IPAA) * Willing to adhere to the diet and behavior modifications required for ESG * Able to follow the visit schedule * Able to provide informed consent * If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum Human Chorionic Gonadotropin (HCG) at screening/baseline Exclusion Criteria: * Prior gastric or bariatric surgery or other alteration to upper gastrointestinal anatomy which would preclude safe or technical performance of ESG * Current or recent (last six months) gastric or duodenal ulceration * Esophageal or gastric varices * Significant motility disorder of the esophagus or stomach * Large hiatal hernia measuring \>5 cm or ≤ 5 cm and associated with severe gastroesophageal reflux * Severe coagulopathy, hepatic insufficiency, or cirrhosis * Gastric mass * Presence of any other medical condition which precludes safe performance of elective endoscopy such as poor general health and/or history of severe hepatic, cardiac, or pulmonary disease * Serious or uncontrolled psychiatric illness which may compromise patient understanding of procedure or compliance with follow-up visits * Unwilling to participate in an established diet and behavior modification program, with routine follow-up * Ongoing corticosteroid use at a dose of \>5 mg daily * Daily use of anti-inflammatory agents such as non-steroidal medications, or anticoagulants without medical supervision * Alcohol or drug addiction * Females who are pregnant, nursing, or planning pregnancy within the next year * Concomitant use of or unwillingness to avoid any use of weight loss medications, weight loss supplements, or weight loss herbal preparations * Has a condition or is in a situation which in the investigator's opinion may put the subject at significant risk or may interfere significantly with the subject's participation in the study
Where this trial is running
Rochester, Minnesota
- Mayo Clinic Minnesota — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Amanda M Johnson, MD — Mayo Clinic
- Study coordinator: ESG with IPAA Study Team
- Email: DLRSTIPAAinfo@mayo.edu
- Phone: 507-538-8238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Ulcerative Colitis, ESG, IPAA