NCT07496840

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Achalasia is a rare esophageal motility disorder characterized by impaired relaxation of the lower esophageal sphincter and absence of normal esophageal peristalsis, resulting in dysphagia and other symptoms. Per-oral endoscopic myotomy (POEM) has emerged as a minimally invasive and effective treatment option for achalasia and other esophageal motility disorders. The Speedboat UltraSlim™ surgical device is a novel endoscopic instrument that enables simultaneous dissection and coagulation, potentially improving procedural efficiency and safety. This study aims to evaluate the technical feasibility, clinical outcomes, and safety profile of POEM procedures performed using this device. This study is designed as a prospective, single-center registry including patients undergoing clinically indicated POEM procedures as part of standard of care. No experimental interventions will be introduced, and all procedures will be performed according to routine clinical practice by experienced endoscopists. Patients will be approached for participation after the clinical decision to perform POEM has been established. Eligible participants include adult patients diagnosed with achalasia or other esophageal motility disorders who are scheduled to undergo POEM. Patients who are not considered appropriate candidates for the procedure or who are under 18 years of age will be excluded. Data will be collected through electronic medical record review and procedural documentation. Variables collected will include patient demographics, clinical characteristics, procedural details (e.g., procedure duration, technical success), and peri-procedural outcomes. Safety outcomes will include intra-procedural and post-procedural adverse events. Follow-up data will be collected at predefined intervals, including approximately 30 days, 3 months, 6 months, and up to 1 year after the procedure. Clinical outcomes will include symptom improvement assessed using validated measures such as the Eckardt score, as well as objective findings from endoscopy and manometry when available. The primary objectives of this registry are to assess technical success, clinical success, and safety outcomes associated with POEM using the Speedboat UltraSlim™ device. Secondary analyses may include evaluation of procedural efficiency, adverse event rates, and need for additional interventions. As this is an observational registry study, participation does not alter clinical management. The study presents minimal risk to participants, primarily related to data confidentiality. All data will be coded and stored in secure, password-protected systems in compliance with institutional policies and applicable regulations. No protected health information will be shared outside the study site.

Conditions

• Esophageal Motility Disorders
• Achalasia

Timeline

• Start date: 2026-01-15
• Primary completion: 2027-07-30
• Completion: 2027-09-30
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States