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RECRUITINGINTERVENTIONAL

A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

Endoscopic Sleeve Gastroplasty (ESG) as a Treatment Option for Obesity in Ulcerative Colitis (UC) Patients Undergoing Colectomy With Ileal Pouch Anal Anastomosis (IPAA)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Apollo Endoscopic Suture System

Endoscopic Sleeve Gastroplasty (ESG), and endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 70-80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall.

BEHAVIORAL

Lifestyle Intervention

Low-calorie healthy diet personalized by a dietician according to individual patients' needs and conducive to weight loss. Physical activity will be encourage and assessed.

Locations (1)

Mayo Clinic Minnesota
Rochester, Minnesota, United States