Speedboat UltraSlim™ for POEM in adults with achalasia and other esophageal motility disorders.
Clinical Outcome, Safety, and Effectiveness Assessment of Speedboat Ultraslim™ Surgical Device in the Performance of Per-Oral Endoscopic Myotomy (POEM)
This registry will see if using the Speedboat UltraSlim™ device for POEM is safe and effective for adults with achalasia or other esophageal motility disorders.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07496840 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center registry enrolling adults who undergo clinically indicated per-oral endoscopic myotomy (POEM) using the Speedboat UltraSlim™ device at Baylor College of Medicine. No experimental interventions are introduced; patients are invited to participate after the clinical decision for POEM has been made. Investigators will collect procedural details, patient demographics, symptom measures, technical and clinical success, and adverse events from electronic medical records with follow-up at 30 days, 3 months, 6 months, and up to one year. The primary focus is to characterize technical feasibility, clinical outcomes, and the safety profile of POEM conducted with this device in routine practice.
Who should consider this trial
Good fit: Adults (age ≥18) diagnosed with achalasia or other esophageal motility disorders who are scheduled for clinically indicated POEM using the Speedboat UltraSlim™ and can provide informed consent.
Not a fit: Patients under 18, those judged inappropriate candidates for POEM, or patients undergoing POEM with different devices are not eligible and would not directly benefit from this registry.
Why it matters
Potential benefit: If successful, the device could improve procedural efficiency and reduce complications, potentially leading to better symptom relief and quicker recovery for patients undergoing POEM.
How similar studies have performed: POEM is well established as an effective treatment for achalasia and other electrosurgical devices have shown improvements in efficiency and safety, but the Speedboat UltraSlim™ is relatively new and has limited published data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥18 years of age) * Diagnosed with achalasia or other esophageal motility disorders * Scheduled to undergo clinically indicated per-oral endoscopic myotomy (POEM) using the Speedboat UltraSlim™ device * Able and willing to provide informed consent Exclusion Criteria: * Patients under 18 years of age * Patients not considered appropriate candidates for POEM by the principal investigator or treating physician
Where this trial is running
Houston, Texas
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Mohamed Othman, MD — Baylor College of Medicine
- Study coordinator: Mohamed Othman, MD
- Email: Mohamed.Othman@bcm.edu
- Phone: 7137980950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.