protocolSection identificationModule nctId: NCT06264466, orgStudyIdInfo id: IECED-010112023, briefTitle: Safety and Efficacy of a Novel Flexible Bipolar in POEM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Instituto Ecuatoriano de Enfermedades Digestivas, class: OTHER, descriptionModule briefSummary: Per-oral endoscopic myotomy (POEM) is a minimally invasive therapy for achalasia. The procedure has demonstrated high technical and clinical success with lower adverse events. Different types of knives have been used for cutting and coagulation during the procedure; however, exchanging accessories is sometimes needed to perform all the stages of POEM.To overcome this disadvantage, the investigators aim to evaluate a single device that integrates in its tip bipolar radiofrequency and microwave, the Speedboat Ultraslim (Creo Medical, UK) for cutting and coagulation during POEM procedure. Some of the promise's advantages derived from its use are: (1) less inflammation, (2) clear differentiation between layers, (3) the use of a single device for the procedure.This single-center, prospective, interventional study will include patients with achalasia submitted to POEM procedure, with or without fundoplication (POEM-F). All stages (mucosal incision, submucosal tunneling, myotomy) of POEM will be performed using the Speedboat ultraslim flexible catheter. Technical and clinical success, along with safety will be the primary endpoints; while, post-procedure reflux symptoms and quality of life will be assessed as secondary outcomes with reflux severity index (RSI) and the Northwestern Esophageal Quality of Life (NEQOL), respectively., conditionsModule conditions: Esophageal Achalasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: interventional trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 73, type: ESTIMATED, armsInterventionsModule interventions name: POEM with Speedboat Ultraslim, outcomesModule primaryOutcomes measure: Technical success of procedure, primaryOutcomes measure: Clinical success of procedure, primaryOutcomes measure: Frequency of adverse events attributable to the procedure, secondaryOutcomes measure: Rate of Gastroesophageal reflux disease, secondaryOutcomes measure: Assessment of Gastroesophageal reflux disease severity, secondaryOutcomes measure: Change in health-related quality of life after POEM, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto Ecuatoriano de Enfermedades Digestivas (IECED), status: RECRUITING, city: Guayaquil, state: Guayas, zip: 090505, country: Ecuador, contacts name: Carlos Robles-Medranda, MD FASGE, role: CONTACT, phone: +593989158865, email: carlosoakm@yahoo.es, contacts role: CONTACT, email: carlosoakm@yahoo.es, contacts name: Carlos Robles-Medranda, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Michel Kahaleh, MD, role: SUB_INVESTIGATOR, contacts name: Eduardo Albeniz, MD, role: SUB_INVESTIGATOR, contacts name: Juan Alcivar-Vasquez, MD, role: SUB_INVESTIGATOR, contacts name: Maria Egas-Izquierdo, MD, role: SUB_INVESTIGATOR, contacts name: Jorge Baquerizo-Burgos, MD, role: SUB_INVESTIGATOR, contacts name: Domenica Cunto, MD, role: SUB_INVESTIGATOR, contacts name: Miguel Puga-Tejada, MD, role: SUB_INVESTIGATOR, contacts name: Martha Arevalo-Mora, MD, role: SUB_INVESTIGATOR, contacts name: Raquel Del Valle, MD, role: SUB_INVESTIGATOR, contacts name: Hannah Pitanga-Lukashok, MD, role: SUB_INVESTIGATOR, geoPoint lat: -2.20584, lon: -79.90795, hasResults: False