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Evaluating Speedboat UltraSlim™ for POEM in Esophageal Motility Disorders

This study is looking at the clinical outcomes, safety, and effectiveness of a medical device called Speedboat UltraSlim™ when used during a procedure called Per-Oral Endoscopic Myotomy (POEM). POEM is a minimally invasive treatment for conditions like achalasia, which is an esophageal motility disorder where your esophagus has trouble moving food down. You may be able to join if you are an adult (18 or older) with achalasia or another esophageal motility disorder and are already scheduled to have a POEM procedure using the Speedboat UltraSlim™ device. The main goal is to see how many participants have a technically successful POEM procedure using this device on the day of the procedure. The study is currently observational, meaning it collects information from your routine care.

Study design
This is an observational study designed to include 40 participants. It is a registry, meaning data will be collected from patients undergoing standard care.
What's involved
You would undergo a clinically indicated POEM procedure as part of your standard care. Data will be collected from your medical records and procedural documents.
Compensation
Not stated in the trial record.
Follow-up
Follow-up data will be collected at predefined time points, but the specific duration is not detailed in this record.

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NCT07496840

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

Recruiting
Not specifiedAges 18+Observational
Baylor College of Medicine
~40 participants
Updated 2026-06-17 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Technical Success of the Per-Oral Endoscopic Myotomy (POEM) Procedure Using the Speedboat UltraSlim™ Device
Measured over Day 0

Conditions

Esophageal Motility Disorders
Achalasia

Explore related trials

AchalasiaEsophageal dysmotility

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Mohamed Othman, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Mohamed Othman, MD
[email protected]
7137980950
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Patients under 18 years of age
Patients not considered appropriate candidates for POEM by the principal investigator or treating physician

What this trial measures

  • Number of Participants with Technical Success of the Per-Oral Endoscopic Myotomy (POEM) Procedure Using the Speedboat UltraSlim™ DeviceDay 0

    Technical success is defined as successful completion of the per-oral endoscopic myotomy (POEM) procedure using the Speedboat UltraSlim™ device as intended, without the need for conversion to an alternative device or procedure.