[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496050":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":57,"collaborators":21,"id":60,"slug":21,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":21,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":21,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":43,"whyStopped":21,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Endoscopic Sleeve Gastroplasty (ESG)","EXPERIMENTAL","Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.",[13,14],"Device: Apollo Endoscopic Suture System","Behavioral: Lifestyle Intervention",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"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.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"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.",[9],[28],{"name":29,"affiliation":5,"role":30},"Amanda M Johnson, MD","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"ESG with IPAA Study Team","CONTACT","507-538-8238","DLRSTIPAAinfo@mayo.edu",{"name":38,"role":34,"phone":35,"phoneExt":21,"email":39},"Abigail A Stromme","stromme.abigail@mayo.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Mayo Clinic Minnesota","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-92.4699,44.02163,{"lat":53,"lon":52},[56],{"name":38,"role":34,"phone":35,"phoneExt":21,"email":39},{"type":30,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Amanda M. Johnson","Principal Investigator","100496050",false,"NCT05739162","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)","Inclusion Criteria:\n\n* BMI 30-50 kg\u002Fm2 for at least 6 months prior to ESG\n* 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)\n* Willing to adhere to the diet and behavior modifications required for ESG\n* Able to follow the visit schedule\n* Able to provide informed consent\n* 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\u002Fbaseline\n\nExclusion Criteria:\n\n* Prior gastric or bariatric surgery or other alteration to upper gastrointestinal anatomy which would preclude safe or technical performance of ESG\n* Current or recent (last six months) gastric or duodenal ulceration\n* Esophageal or gastric varices\n* Significant motility disorder of the esophagus or stomach\n* Large hiatal hernia measuring \\>5 cm or ≤ 5 cm and associated with severe gastroesophageal reflux\n* Severe coagulopathy, hepatic insufficiency, or cirrhosis\n* Gastric mass\n* Presence of any other medical condition which precludes safe performance of elective endoscopy such as poor general health and\u002For history of severe hepatic, cardiac, or pulmonary disease\n* Serious or uncontrolled psychiatric illness which may compromise patient understanding of procedure or compliance with follow-up visits\n* Unwilling to participate in an established diet and behavior modification program, with routine follow-up\n* Ongoing corticosteroid use at a dose of \\>5 mg daily\n* Daily use of anti-inflammatory agents such as non-steroidal medications, or anticoagulants without medical supervision\n* Alcohol or drug addiction\n* Females who are pregnant, nursing, or planning pregnancy within the next year\n* Concomitant use of or unwillingness to avoid any use of weight loss medications, weight loss supplements, or weight loss herbal preparations\n* 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","ALL","22 Years","69 Years",{"count":70,"type":71},12,"ESTIMATED","INTERVENTIONAL",[74],"NA","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.",[77,78],"Obesity","Ulcerative Colitis",[80,81],"ESG","IPAA","2025-11-24",{"date":84,"type":85},"2025-12-01","ACTUAL",{"date":87,"type":85},"2023-09-20",{"date":89,"type":71},"2027-01",{"name":5,"class":6},1]