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NCT07496840 · ClinicalTrials.gov registry record
Clinical Outcomes, Safety, and Effectiveness of Speedboat UltraSlim™ in Per-Oral Endoscopic Myotomy (POEM)
A clinical trial, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- 40
- Enrollment target
NCT07496840: Recruiting study, sponsored by Baylor College of Medicine.
NCT07496840 is a clinical trial that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07496840 is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-01-15 |
| Est. Completion | 2027-09-30 |
What NCT07496840 shows while recruiting
NCT07496840 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT07496840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07496840 about?
NCT07496840 is a clinical study titled "Clinical Outcomes, Safety, and Effectiveness of Speedboat UltraSlim™ in Per-Oral Endoscopic Myotomy (POEM)". 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 ...
What is the current status of trial NCT07496840?
This trial is currently recruiting. The enrollment target is 40 participants. The study started on 2026-01-15. Estimated completion is 2027-09-30.
Who is sponsoring clinical trial NCT07496840?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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