NCT05739162
A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
Active, Not Recruiting
NAAges 22–69InterventionalTreatmentMayo ClinicInvestigator-initiated
~2 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Apollo Endoscopic Suture SystemLifestyle Intervention
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Total Body Weight Loss
Measured over 6 months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Study leadership
- Amanda M Johnson, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Percent Total Body Weight Loss6 months
Percent total body weight loss (%TBWL) calculated by the equation ((baseline screening weight in kilograms (kg) subtracted by follow-up weight in kg) divided by baseline screening weight in kg) times 100.
- Number of Subjects With Serious Adverse Events24 months
Total number of subjects to report serious adverse event related to the ESG procedure