Safety and Efficacy of a Novel Flexible Bipolar in POEM

NARecruitingINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

December 1, 2024

Study Completion Date

January 15, 2025

Conditions
Esophageal Achalasia
Interventions
DEVICE

POEM with Speedboat Ultraslim

POEM procedures, with or without fundoplication, will be conducted by expert endoscopists who have undergone prior training in the utilization of the ultraslim Speedboat. Incisions, whether anterior or posterior, submucosal tunneling, and myotomy will be performed using the Bipolar Radiofrequency Ablation (RFA) integrated into the device's tip. Additionally, for vessel coagulation, the microwave energy integrated into the device's tip will be employed. Successful myotomy will be confirmed by passage of the endoscope through the esophagogastric junction (EGJ) without restriction.

Trial Locations (1)

090505

RECRUITING

Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil

All Listed Sponsors
lead

Instituto Ecuatoriano de Enfermedades Digestivas

OTHER