[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539115":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":60,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":42,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":42,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":100,"whyStopped":42,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Belt and Suspenders Configuration","ACTIVE_COMPARATOR","Endoscopic sleeve gastroplasty with the Endomina system creating proximal and distal gastric plications (belt and suspenders configuration).",[13],"Device: Endoscopic Sleeve Gastroplasty - Belt and Suspenders",{"label":15,"type":10,"description":16,"interventionNames":17},"Belt Configuration","Endoscopic sleeve gastroplasty with the Endomina system creating distal gastric plications (belt configuration).",[18],"Device: Endoscopic Sleeve Gastroplasty - Belt",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Endoscopic Sleeve Gastroplasty - Belt and Suspenders","Endoscopic sleeve gastroplasty using belt and suspender plications.",[9],[26],"Belt and Suspenders ESG",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Endoscopic Sleeve Gastroplasty - Belt","Endoscopic sleeve gastroplasty using belt only plications.",[15],[32],"Belt ESG",[34],{"name":35,"affiliation":5,"role":36},"Christopher C Thompson, MD, MSc","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Michele B Ryan, MS","CONTACT","617-525-8266",null,"mryan@bwh.harvard.edu",{"name":45,"role":40,"phone":41,"phoneExt":42,"email":46},"Samantha Geltz","sgeltz@bwh.harvard.edu",[48],{"facility":5,"status":42,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":42},"Boston","Massachusetts","02115","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-71.05977,42.35843,{"lat":58,"lon":57},{"type":36,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Christopher C. Thompson, MD, MSc","Director of Endoscopy",[64],{"name":65,"class":66},"Endo Tools Therapeutics S.A.","INDUSTRY","100539115","endoscopic-sleeve-gastroplasty-technique-comparison-for-weight-loss-100539115",false,"NCT06299644","Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss","Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss Using the Endomina Plicating Device: A Randomized Trial","Inclusion Criteria:\n\n1. Patients with 18-65 years of age\n2. BMI ≥ 30 kg\u002Fm2\n3. Capable of giving informed consent and available to return for follow-up visit\n\nExclusion Criteria:\n\n1. Untreated H. pylori infection\n2. Active gastric or duodenal ulceration\n3. Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST))\n4. Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D)\n5. Esophageal or gastric varices and\u002For portal hypertensive gastropathy\n6. Gastroparesis\n7. History of gastric surgery\u002Fendoscopic procedure\n8. Active psychological issues preventing participation in a lifestyle modification program\n9. Known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)\n10. Severe coagulopathy\n11. Active smoking\n12. Substance abuse\n13. Serious health condition that increased risk of anesthesia and\u002For endoscopic procedure\n14. Pregnancy or lactation\n15. Patients who require Non-Steroidal Anti-inflammatory Drugs (NSAID) use","ALL","18 Years","65 Years",{"count":78,"type":79},10,"ESTIMATED","INTERVENTIONAL",[82],"NA","The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare \"belt\" with \"belt and suspenders\" plication pattern using the Endomina system to determine percent total weight loss.",[85,86,87,88],"Obesity","Obesity, Morbid","Metabolic Disease","Weight, Body",[90,91,92,93,94,95,96,97,98,99],"Endoscopic Bariatric and Metabolic Therapies (EBMT)","Endoscopic Bariatric Therapies (EBT)","Gastric emptying","Endoscopic Suturing","endoscopic sleeve gastroplasty (ESG)","Weight Loss","Bariatric Endoscopy","Weight Management","Endoscopic plication","Gastric plication","NOT_YET_RECRUITING","2025-11-25",{"date":103,"type":104},"2025-12-02","ACTUAL",{"date":106,"type":79},"2026-09",{"date":108,"type":79},"2028-05",{"name":5,"class":6},1]