Actively Recruiting
A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
Led by Mayo Clinic · Updated on 2025-12-01
12
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI 30-50 kg/m2 for at least 6 months prior to ESG
- Diagnosis of ulcerative colitis with plans to undergo or who have already undergone colectomy for eventual ileal pouch anal anastomosis (IPAA)
- Willing to follow diet and behavior modifications required for ESG
- Able to attend all study visits
- Able to provide informed consent
- If female, must be post-menopausal, surgically sterile, or agree to use birth control during the study year and have a negative pregnancy test at screening/baseline
You will not qualify if you...
- Prior gastric or bariatric surgery or upper gastrointestinal changes preventing safe ESG
- Current or recent (last 6 months) gastric or duodenal ulcers
- Esophageal or gastric varices
- Significant esophagus or stomach motility disorders
- Large hiatal hernia (>5 cm) or ≤5 cm with severe reflux
- Severe bleeding disorders, liver failure, or cirrhosis
- Gastric tumors
- Any medical condition posing high risk or preventing safe endoscopy such as severe liver, heart, or lung disease
- Serious uncontrolled psychiatric illness affecting understanding or compliance
- Unwillingness to participate in diet and behavior program with follow-up
- Using corticosteroids over 5 mg daily
- Daily use of anti-inflammatory or anticoagulant drugs without supervision
- Alcohol or drug addiction
- Females who are pregnant, nursing, or planning pregnancy within a year
- Use or unwillingness to avoid weight loss drugs, supplements, or herbal products
- Any condition or situation judged by the investigator to pose significant risk or interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
E
ESG with IPAA Study Team
CONTACT
A
Abigail A Stromme
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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