[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606689":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":66,"collaborators":69,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":31,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":25,"enrollmentInfo":87,"targetDuration":25,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":106,"whyStopped":25,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of California, Irvine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional POEM","ACTIVE_COMPARATOR","Participants in this arm will undergo standard peroral endoscopic myotomy (POEM), including myotomy of circular and sling muscle fibers at the gastric side.",[13],"Procedure: Conventional POEM",{"label":15,"type":16,"description":17,"interventionNames":18},"Sling Fiber-Preservation POEM","EXPERIMENTAL","Participants in this arm will undergo posterior POEM with selective preservation of the gastric sling fibers. Myotomy is performed to the right of the second penetrating vessel to spare the sling fibers. The double scope technique will be employed to confirm that the tunnel ends on the lesser curve, which confirms sparing of the sling fibers.",[19],"Procedure: Sling Fiber-Preserving POEM",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Standard posterior POEM with full-thickness myotomy, including both circular and gastric sling muscle fibers.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Sling Fiber-Preserving POEM","Posterior POEM with selective preservation of gastric sling fibers by limiting myotomy to the right of the second penetrating vessel.",[15],[31],"SFP-POEM",[33],{"name":34,"affiliation":5,"role":35},"Jason Samarasena, MD, MBA","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Frances Dang, MD, MSc","CONTACT","714-456-6745","dangf1@hs.uci.edu",{"name":43,"role":39,"phone":44,"phoneExt":25,"email":45},"Jason Samarasena, MD","714-456-7447","jsamaras@hs.uci.edu",[47],{"facility":48,"status":25,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University of California, Irvine - UCI Medical Center","Orange","California","92868","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-117.85311,33.78779,{"lat":58,"lon":57},[61,63,64],{"name":62,"role":39,"phone":44,"phoneExt":25,"email":41},"Frances Dang, MD",{"name":34,"role":35,"phone":25,"phoneExt":25,"email":25},{"name":62,"role":65,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"type":35,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Frances Dang","Assistant Clinical Professor",[70,72,74,76],{"name":71,"class":6},"Hoag Memorial Hospital Presbyterian",{"name":73,"class":6},"University of Ottawa",{"name":75,"class":6},"Vancouver General Hospital",{"name":77,"class":6},"Cedars-Sinai Medical Center","100606689","sling-fiber-preservation-poem-vs-conventional-poem-for-reducing-post-poem-gerd-100606689",false,"NCT07178821","Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD","Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD: A Randomized Control Trial","Inclusion Criteria (Participants must meet all of the following):\n\n* Age ≥ 18 years\n* Diagnosis of achalasia (Type I-III) per Chicago Classification v3.0\n* Deemed appropriate candidates for POEM\n* Ability to provide informed consent\n\nExclusion Criteria (Participants will be excluded if any of the following apply):\n\n* Spastic motility disorders other than achalasia type I-III (e.g. diffuse esophageal spasm, jackhammer esophagus, EGJ outflow obstruction)\n* Sigmoid esophagus\n* Prior surgical myotomy (e.g., Heller myotomy)\n* Contraindications to endoscopy or general anesthesia\n* Pregnancy or actively breastfeeding\n* Significant cardiopulmonary comorbidities that preclude safe endoscopic intervention\n* Coagulopathy or portal hypertension\n* Unwillingness or inability to complete follow-up assessments","ALL","18 Years",{"count":88,"type":89},120,"ESTIMATED","INTERVENTIONAL",[92],"NA","Peroral endoscopic myotomy (POEM) is an effective, minimally invasive treatment for achalasia, offering excellent rates of symptom relief. However, a significant drawback is the high incidence of gastroesophageal reflux disease (GERD) following the procedure. One proposed technical modification, the selective preservation of the sling fibers during gastric myotomy (SFP-POEM), may reduce this risk without compromising efficacy as compared to a conventional POEM procedure, which includes myotomy of the sling fibers. In this study, adults with achalasia will be randomly assigned to receive one of the two POEM technical approaches. Researchers will monitor whether preserving sling fibers reduces the rates of reflux esophagitis (classified as Los Angeles Grade B or higher) on follow-up endoscopy. Participants will be followed for up to 1 year after the procedure.",[95,96],"Achalasia, Esophageal","GERD (Gastroesophageal Reflux Disease)",[98,99,100,101,31,102,103,104,105],"Achalasia","POEM","Peroral Endoscopic Myotomy","Sling Fiber Preservation","Gastroesophageal Reflux","GERD","Reflux Esophagitis","Randomized Controlled Trial","NOT_YET_RECRUITING","2025-10-20",{"date":109,"type":110},"2025-10-22","ACTUAL",{"date":112,"type":89},"2025-12-01",{"date":114,"type":89},"2028-01-01",{"name":5,"class":6},1]