NCT05739162 A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
| NCT ID | NCT05739162 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-09-20 |
| Primary Completion | 2026-06 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
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
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