New Stomach-Slimming procedure tested for ulcerative colitis patients
NCT ID NCT05739162
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 4 times
Summary
This study is testing a minimally invasive weight loss procedure called endoscopic sleeve gastroplasty (ESG) in 12 people who have both obesity and ulcerative colitis and are planning or have had colon removal surgery. The procedure uses a suturing device to reduce stomach size by 70-80%, and participants also follow a personalized low-calorie diet and exercise plan. The goal is to see if ESG is safe and effective for weight loss in this specific group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Endoscopic sleeve gastroplasty (ESG) using the Apollo Endoscopic Suture System, plus a personalized low-calorie diet and physical activity plan
- What this could lead to
- If it works, this could offer a safe weight-loss option for obese UC patients before or after colon removal surgery, potentially reducing surgical complications.
- What could go wrong
- This is a very small early study (12 people) with no control group, so results may not apply broadly. The procedure carries risks like bleeding or infection, and weight loss may not be sustained.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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2 people
The number who actually took part.
- Started
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Sep 2023
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 69 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic Minnesota
Rochester, Minnesota, 55905, United States
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