Clinical trial Recruiting at 1 site Observational Ages 18 and up

Speedboat UltraSlim™ for POEM in adults with achalasia and other esophageal motility disorders.

Official title: Clinical Outcome, Safety, and Effectiveness Assessment of Speedboat Ultraslim™ Surgical Device in the Performance of Per-Oral Endoscopic Myotomy (POEM)

Run by Baylor College of Medicine · NCT07496840 · Data updated 2026-11-12

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.

More Achalasia trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorBaylor College of Medicine
Academic / other
Locations1 site (Houston, Texas)
StatusRecruiting
StartedJanuary 15, 2026
Main results expectedJuly 30, 2027
Study endsSeptember 30, 2027
Registry record updatedJune 17, 2026
Trial IDNCT07496840 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.