Clinical Outcome, Safety, and Effectiveness Assessment of Speedboat UltraSlim173 Surgical Device in Per-Oral Endoscopic Myotomy (POEM)

What this Trial Is About

This research aims to evaluate the clinical outcomes, safety, and effectiveness of the Speedboat UltraSlim173 device when used during per-oral endoscopic myotomy (POEM) procedures in adults with achalasia or other esophageal motility disorders. Achalasia is a rare condition where the lower esophageal sphincter does not relax properly, causing swallowing difficulties. POEM has become a minimally invasive treatment option, and this study focuses on assessing the use of this novel device which allows simultaneous dissection and coagulation during the procedure. Participants are adults diagnosed with achalasia or similar esophageal motility disorders who are already scheduled for POEM as part of their standard care. No experimental treatments are given; the study observes patients undergoing POEM using the Speedboat UltraSlim173 device, performed by experienced endoscopists following routine clinical practice. Data collection includes patient information, procedural details, and outcomes from the procedure. During the study, researchers will gather data from medical records and procedural documentation before and after the POEM procedure. Follow-up assessments will occur at around 30 days, 3 months, 6 months, and up to one year to evaluate symptom improvement using scores like the Eckardt score, procedural success, and any adverse events. The study primarily measures the technical success of POEM with this device and monitors safety outcomes, with all information securely stored to protect patient confidentiality.

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