Evaluating Safety and Effectiveness of the Speedboat UltraSlim Device in Per-Oral Endoscopic Myotomy POEM for Achalasia and Esophageal Motility Disorders

What this Trial Is About

This research aims to evaluate the outcomes, safety, and effectiveness of per-oral endoscopic myotomy POEM performed using the Speedboat UltraSlim17 device in adults with achalasia or other esophageal motility disorders. Achalasia is a rare condition that affects the esophagus ability to move food toward the stomach, causing swallowing difficulties. The study is a prospective registry designed to collect real-world data from patients receiving clinically indicated POEM as part of standard care. Participants undergo POEM using the Speedboat UltraSlim17 device, a novel endoscopic tool that allows for simultaneous dissection and coagulation during the procedure, potentially improving efficiency and safety. No experimental treatments are given, as all procedures follow routine clinical practice by experienced doctors. Data are gathered from medical records and procedural notes, without additional interventions. During the study, researchers collect information about patient characteristics, procedure details, and safety outcomes such as adverse events. Follow-up assessments occur at about 30 days, 3 months, 6 months, and up to one year after the procedure to evaluate symptom improvement using measures like the Eckardt score and objective tests if available. The main outcomes focus on technical success of the procedure, clinical symptom improvement, and safety. Participation involves minimal risk since no extra procedures beyond standard care are required.

Clinical Outcomes, Safety, and Effectiveness of Speedboat UltraSlim™ in Per-Oral Endoscopic Myotomy (POEM)