A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

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 aspart 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 birthcontrol 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 gastrointestinalanatomy 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 severegastroesophageal reflux

• Severe coagulopathy, hepatic insufficiency, or cirrhosis

• Gastric mass

• Presence of any other medical condition which precludes safe performance of electiveendoscopy such as poor general health and/or history of severe hepatic, cardiac, orpulmonary disease

• Serious or uncontrolled psychiatric illness which may compromise patientunderstanding 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, oranticoagulants 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 thesubject at significant risk or may interfere significantly with the subject'sparticipation in the study