A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

Mayo Clinic

Status: Enrolling

Conditions: Obesity; Ulcerative Colitis

Treatments: Behavioral: Lifestyle Intervention; Device: Apollo Endoscopic Suture System

Study type: Interventional

Funder types: Other

Identifiers

NCT05739162

22-007643

Details and patient eligibility

About

The purpose of this research is to gather information on the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) for weight loss in a population of obese UC patients undergoing colectomy with eventual IPAA.

Enrollment: 12 estimated patients

Sex: All

Ages: 22 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Endoscopic Sleeve Gastroplasty (ESG)

Experimental group

Description:

Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.

Treatment:

Device: Apollo Endoscopic Suture System

Behavioral: Lifestyle Intervention