Clinical Research Directory

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

Sponsor: Baylor College of Medicine

Summary

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. Participants 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. Data 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. The 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. This 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.

Official title: CLINICAL OUTCOME, SAFETY, AND EFFECTIVENESS ASSESSMENT OF SPEEDBOAT UTRASLIM™ SURGICAL DEVICE IN THE PERFORMANCE OF PER-ORAL ENDOSCOPIC MYOTOMY (POEM)

Key Details

Conditions

Locations (1)