[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631143":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":24,"responsibleParty":52,"collaborators":10,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":10,"overallStatus":26,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Baylor College of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients Undergoing POEM Using Speedboat UltraSlim™",null,"Patients with achalasia or other esophageal motility disorders undergoing clinically indicated per-oral endoscopic myotomy (POEM) using the Speedboat UltraSlim™ device as part of standard clinical care. No experimental interventions are performed.",[13],{"name":14,"affiliation":5,"role":15},"Mohamed Othman, MD","PRINCIPAL_INVESTIGATOR",[17,21],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":20},"CONTACT","7137980950","Mohamed.Othman@bcm.edu",{"name":22,"role":18,"phone":10,"phoneExt":10,"email":23},"Mai Khalaf","Mai.Khalaf@bcm.edu",[25],{"facility":5,"status":26,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"RECRUITING","Houston","Texas","77030","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-95.36327,29.76328,{"lat":36,"lon":35},[39,41,45,48,50],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":40},"mohamed.othman@bcm.edu",{"name":42,"role":18,"phone":43,"phoneExt":10,"email":44},"Haydee Rochits Cueto","7137983606","Haydee.RochitsCueto@bcm.edu",{"name":46,"role":47,"phone":10,"phoneExt":10,"email":10},"Salmaan Jawaid, MD","SUB_INVESTIGATOR",{"name":49,"role":47,"phone":10,"phoneExt":10,"email":10},"Tara Keihanian, MD",{"name":51,"role":47,"phone":10,"phoneExt":10,"email":10},"Fares Ayoub, MD",{"type":15,"investigatorFullName":14,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Principal Investigator","100631143","clinical-outcomes-safety-and-effectiveness-of-speedboat-ultraslim-in-per-oral-endoscopic-myotomy-poem-100631143",false,"NCT07496840","Clinical Outcomes, Safety, and Effectiveness of Speedboat UltraSlim™ in Per-Oral Endoscopic Myotomy (POEM)","Clinical Outcome, Safety, and Effectiveness Assessment of Speedboat Ultraslim™ Surgical Device in the Performance of Per-Oral Endoscopic Myotomy (POEM)","SU-POEM","Inclusion Criteria:\n\n* Adult patients (≥18 years of age)\n* Diagnosed with achalasia or other esophageal motility disorders\n* Scheduled to undergo clinically indicated per-oral endoscopic myotomy (POEM) using the Speedboat UltraSlim™ device\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Patients not considered appropriate candidates for POEM by the principal investigator or treating physician","ALL","18 Years",{"count":65,"type":66},40,"ESTIMATED","OBSERVATIONAL","This study is a prospective registry designed to evaluate the clinical outcomes, safety, and effectiveness of per-oral endoscopic myotomy (POEM) performed using the Speedboat UltraSlim™ device in patients with achalasia or other esophageal motility disorders.\n\nParticipants included in this registry are those undergoing clinically indicated POEM as part of standard of care. No experimental interventions will be performed as part of this study. Patients will be approached for participation after the clinical decision to perform POEM has already been made.\n\nData will be collected through review of electronic medical records and procedural documentation, including patient demographics, procedural details, and clinical outcomes. Follow-up data will be collected at predefined time points (e.g., 30 days, 3 months, 6 months, and up to 1 year) to assess symptom improvement, procedural success, and adverse events.\n\nThe primary objective of the study is to assess technical success, clinical success, and safety outcomes associated with the use of the Speedboat UltraSlim™ device during POEM procedures.\n\nThis registry poses minimal risk to participants, as all procedures are performed as part of routine clinical care. No additional interventions beyond standard care are required for participation.",[70,71],"Esophageal Motility Disorders","Achalasia","2026-06-16",{"date":74,"type":75},"2026-06-17","ACTUAL",{"date":77,"type":75},"2026-01-15",{"date":79,"type":66},"2027-09-30",{"name":5,"class":6},1]