[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594129":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":31,"locations":37,"responsibleParty":184,"collaborators":25,"id":186,"slug":187,"hasResults":188,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":188,"sex":194,"minAge":195,"maxAge":25,"enrollmentInfo":196,"targetDuration":25,"studyType":199,"phases":200,"briefSummary":202,"conditions":203,"keywords":206,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},{"fullName":5,"class":6},"Boston Scientific Corporation","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"TORe and Lifestyle Modification Arm","ACTIVE_COMPARATOR","Subjects will receive a TORe procedure and intensive lifestyle modification throughout the study",[13,14],"Device: TORe with OverStitch","Behavioral: Intensive lifestyle modification",{"label":16,"type":10,"description":17,"interventionNames":18},"Lifestyle Modification Arm","Subjects will receive intensive lifestyle modification throughout the study. At 6 months post enrollment, subjects will be eligible to receive a TORe procedure.",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","TORe with OverStitch","Transoral Outlet Reduction with OverStitch Endoscopic Suturing System",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"BEHAVIORAL","Intensive lifestyle modification","Intensive lifestyle modification program consists of the following: well-balanced calorie-restrictive diet, incorporation of exercise and coaching on lifestyle changes. The program should include personal discussions and goals designed and overseen by the treating physician, obesity management professional or dietician.",[16,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Victoria Lazzari","CONTACT","508-561-7296","victoria.lazzari@bsci.com",[38,59,75,91,106,121,137,153,168],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Hoag Memorial Hospital","RECRUITING","Irvine","California","92618","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-117.82311,33.66946,{"lat":50,"lon":49},[53,56],{"name":54,"role":34,"phone":25,"phoneExt":25,"email":55},"Laurie Hendricks","laurie.hendricks@hoag.org",{"name":57,"role":58,"phone":25,"phoneExt":25,"email":25},"Jennifer Phan, MD","PRINCIPAL_INVESTIGATOR",{"facility":60,"status":61,"city":62,"state":42,"zip":63,"country":44,"countryCode":45,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Stanford University Medical Center","NOT_YET_RECRUITING","Stanford","94305",{"type":47,"coordinates":65},[66,67],-122.16608,37.42411,{"lat":67,"lon":66},[70,73],{"name":71,"role":34,"phone":25,"phoneExt":25,"email":72},"Anisha Abreo","aabreo@stanford.edu",{"name":74,"role":58,"phone":25,"phoneExt":25,"email":25},"Micaela Esquivel, MD",{"facility":76,"status":40,"city":77,"state":78,"zip":79,"country":44,"countryCode":45,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Mayo Clinic","Jacksonville","Florida","32224",{"type":47,"coordinates":81},[82,83],-81.65565,30.33218,{"lat":83,"lon":82},[86,89],{"name":87,"role":34,"phone":25,"phoneExt":25,"email":88},"Kim Hall","Hall.Kimberly@mayo.edu",{"name":90,"role":58,"phone":25,"phoneExt":25,"email":25},"Victoria Gomez, MD",{"facility":92,"status":40,"city":93,"state":78,"zip":94,"country":44,"countryCode":45,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Orlando Health Inc","Orlando","32806",{"type":47,"coordinates":96},[97,98],-81.37924,28.53834,{"lat":98,"lon":97},[101,104],{"name":102,"role":34,"phone":25,"phoneExt":25,"email":103},"Leticia Morales","Leticia.Morales@orlandohealth.com",{"name":105,"role":58,"phone":25,"phoneExt":25,"email":25},"Andre Teixeira, MD",{"facility":107,"status":61,"city":108,"state":78,"zip":109,"country":44,"countryCode":45,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"University of South Florida","Tampa","33606",{"type":47,"coordinates":111},[112,113],-82.45843,27.94752,{"lat":113,"lon":112},[116,119],{"name":117,"role":34,"phone":25,"phoneExt":25,"email":118},"Ilexsius Fiorillo","ilexsius@usf.edu",{"name":120,"role":58,"phone":25,"phoneExt":25,"email":25},"Salvatore Docimo, DO",{"facility":122,"status":61,"city":123,"state":124,"zip":125,"country":44,"countryCode":45,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Rush University Medical Center","Chicago","Illinois","60612",{"type":47,"coordinates":127},[128,129],-87.65005,41.85003,{"lat":129,"lon":128},[132,135],{"name":133,"role":34,"phone":25,"phoneExt":25,"email":134},"Amanda Lin","amanda_f_lin@rush.edu",{"name":136,"role":58,"phone":25,"phoneExt":25,"email":25},"Christopher Chapman, MD",{"facility":138,"status":40,"city":139,"state":140,"zip":141,"country":44,"countryCode":45,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Mayo Clinic Foundation","Rochester","Minnesota","55905",{"type":47,"coordinates":143},[144,145],-92.4699,44.02163,{"lat":145,"lon":144},[148,151],{"name":149,"role":34,"phone":25,"phoneExt":25,"email":150},"Liz Lemke","lemke.elizabeth@mayo.edu",{"name":152,"role":58,"phone":25,"phoneExt":25,"email":25},"Eric J Vargas Valls, MD",{"facility":154,"status":61,"city":155,"state":155,"zip":156,"country":44,"countryCode":45,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"NYU Grossman School of Medicine","New York","10016",{"type":47,"coordinates":158},[159,160],-74.00597,40.71427,{"lat":160,"lon":159},[163,166],{"name":164,"role":34,"phone":25,"phoneExt":25,"email":165},"Valeria Pasuizaca","valeria.pasuizaca-yanez@nyulangone.org",{"name":167,"role":58,"phone":25,"phoneExt":25,"email":25},"Rabia De Latour, MD",{"facility":169,"status":61,"city":170,"state":171,"zip":172,"country":44,"countryCode":45,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"University of Texas Houston Health Science Center","Houston","Texas","77030",{"type":47,"coordinates":174},[175,176],-95.36327,29.76328,{"lat":176,"lon":175},[179,182],{"name":180,"role":34,"phone":25,"phoneExt":25,"email":181},"Angielyn Rivera","Angielyn.r.rivera@uth.tmc.edu",{"name":183,"role":58,"phone":25,"phoneExt":25,"email":25},"Erik Wilson, MD",{"type":185,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100594129","randomized-study-on-transoral-outlet-reduction-and-lifestyle-changes-for-weight-regain-after-gastric-bypass-100594129",false,"NCT07015424","Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass","Prospective, Randomized Clinical Study Evaluating Transoral Outlet Reduction (TORe) and Lifestyle Modification for Patients With Weight Regain Following Roux-en-Y Gastric Bypass","REIGNITE","Inclusion Criteria:\n\n* 18 years or older.\n* Experiencing weight regain (≥ 20% weight from nadir) after achieving clinically successful weight loss.\n* Willing to have a TORe procedure for the treatment of weight regain.\n* BMI between 30 and 50 kg\u002Fm2, inclusive.\n* GJA diameter ≥ 20 mm, confirmed either during a\n* Screening EGD completed ≤ 60 days from study procedure or\n* EGD performed immediately prior to the TORe procedure.\n* Anatomically accepting of the procedure, including a pouch size that will not require reduction at the time of treatment (pouch that is shorter than 6 cm in length).\n* Agrees not to take additional over the counter or prescribed weight loss supplements \u002F medications (including incretins) during the first 6 months of the study.\n* Is on a stable dose of anti-diabetic medication for three months with no anticipated changes during the first 6 months of the study.\n* Agrees to the follow-up requirements of the study and is able to read, understand, and sign a written Informed Consent Form to participate in the study.\n* Meets the indications for TORe procedure with OverStitch™ Endoscopic Suturing System.\n\nExclusion Criteria:\n\n* Current use or use within the three months prior to the baseline visit of over the counter or prescribed weight loss supplements \u002F medications (including incretins).\n* Current or planned management of Type 2 Diabetes with incretin medications.\n* Inability or unwillingness to comply with assigned treatment or protocol requirements related to visits.\n* Investigator's medical judgement that the subject is not a candidate for the TORe procedure.\n* Current pregnancy confirmed by site standard of care or planned pregnancy or breastfeeding in the next two years.\n* Vulnerable subject.","ALL","18 Years",{"count":197,"type":198},108,"ESTIMATED","INTERVENTIONAL",[201],"NA","The goal of this clinical trial is to evaluate weight loss with TORe and intensive lifestyle modification versus intensive lifestyle modification alone in subjects who have regained weight following a Roux-en-Y gastric bypass.\n\nParticipants will randomized 2:1. Those randomized to the TORe arm will receive a TORe procedure and intensive lifestyle modification which consists of a well-balanced calorie restrictive diet, incorporation of exercise and coaching on lifestyle discussion. Participants randomized the lifestyle modification alone arm will be eligible to receive a TORe procedure at 6 months post enrollment. Total follow up will be 24 months.",[204,205],"Weight Regain","Weight Loss",[207,208],"TORe","OverStitch","2026-06-11",{"date":211,"type":212},"2026-06-12","ACTUAL",{"date":214,"type":212},"2026-04-14",{"date":216,"type":198},"2028-11",{"name":5,"class":6},9]