[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638169":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":30,"responsibleParty":47,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":11,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":11,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Cairo University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention arm","EXPERIMENTAL",null,[13],"Procedure: Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"PROCEDURE","Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM)","All patients in intervention arm will undergo the following steps:\n\nA. GFMA:\n\nInjection of saline\u002Fmethylene blue solution in the gastric fundal submucosa including the fundal dome and upper half of the greater curvature, sparing 1cm just below the cardia and the whole lesser curvature opposite this area. Argon plasma coagulation will then be applied to ablate the mucosa of this area using ERBE VIO3 generator with settings of Pulsed APC, Effect 2, flow rate 1 L\u002Fminutes, 50-60W to achieve a golden yellow discoloration of the mucosa\n\nB. BEAM will then be performed during the same exam as follows:\n\n1. Submucosal injection by saline in the distal greater curvature about 8 cm proximal to the pylorus.\n2. Using an ESD knife, a mucosal incision will be performed horizontally in the injected bleb\n3. Submucosal tunneling down to the pyloric muscle\n4. Partial thickness antral myotomy along the tunnel 1cm proximal to the pyloric muscle\n5. Mucosal incision site will be sealed by endoscopic clips",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Hany Shehab, MD, FRCP","CONTACT","+201111111071","h.shehab@kasralainy.edu.eg",{"name":27,"role":23,"phone":28,"phoneExt":11,"email":29},"Fatma Elrashdy","+201009454517","fatmaelrashdy@kasralainy.edu.eg",[31],{"facility":32,"status":33,"city":34,"state":11,"zip":11,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Kar-Alaini hospital (Cairo Univeristy hospital)","RECRUITING","Cairo","Egypt","EG",{"type":38,"coordinates":39},"Point",[40,41],31.24967,30.06263,{"lat":41,"lon":40},[44],{"name":45,"role":23,"phone":11,"phoneExt":11,"email":46},"hany shehab","h.shehab@drshehab.com",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Hany Shehab","Professor","100638169","phase-2-bariatric-endoscopic-antral-myotomy-combined-with-fundal-gastric-mucosal-ablation-100638169",false,"NCT07612527","Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation","Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation for The Management of Obesity","Inclusion Criteria:\n\nBody mass index (BMI) of ≥ 30 kg\u002Fm2 up to 40 kg\u002Fm2. BMI of 27.0 to 29.9 kg\u002Fm2 will be included on the condition of the presence of at least 1 obesity-related comorbidity (Indications based according to the American and European societies for bariatric endoscopy guidelines)\n\nExclusion Criteria:\n\n* Subjects with any previous surgeries to the stomach\n* Any previous bariatric procedures\n* Any current medications for the management of obesity (must be stopped at least 3 months before recruitment)\n* Evidence of severe gastritis, gastric peptic ulcer, or gastric cancer\n* Coagulopathy\n* Pregnancy","ALL","18 Years",{"count":61,"type":62},10,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","The gastric fundus regulates appetite through orexigenic ghrelin-mediated and anorexigenic visceroceptive pathways. Accordingly, endoscopic gastric fundal mucosal ablation (GFMA) may benefit patients with obesity. Ablation not only affects these mechanisms, but similar to what happens after mucosal ablation for other indications (e.g. ESD for tumor removal), it is expected to cause shrinking of the fundus and reduce gastric volume.\n\nAnother potential target to achieve weight loss is gastric emptying. This is a critical step in digestion that has been found to be more rapid after prolonged exposure to a high-fat diet in both animal and human studies, with rapid emptying also being more common in young people with obesity in some studies. The bariatric endoscopic antral myotomy (BEAM) procedure has been shown to consistently delay gastric emptying without triggering symptoms of gastroparesis and to produce substantial weight loss.\n\nBoth GFMA and BEAM procedures have the advantages of being minimally invasive, performed completely endoscopic and less costly than surgical alternatives or other known endoscopic techniques like intragastric balloon or endoscopic sleeve gastroplasty.",[68,69],"Obesity & Overweight","Bariatric Endoscopy","2026-08-20",{"date":72,"type":73},"2026-08-21","ACTUAL",{"date":70,"type":73},{"date":76,"type":62},"2027-12",{"name":5,"class":6},1]