Status:
ACTIVE_NOT_RECRUITING
U-POEM vs CO2-POEM
Lead Sponsor:
AdventHealth
Collaborating Sponsors:
University of Florida
California Pacific Medical Center
Conditions:
Esophageal Motility Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multicenter randomized trial comparing post-procedural pain intensity after Per-Oral endoscopic myotomy (POEM) between two types of standard of care insufflation methods (CO2 vs Underwater). POEM is ...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Ability to provide informed consent
- Patient scheduled to undergo POEM procedure for esophageal dysmotility
Exclusion
- Inability to provide informed consent
- Any contraindication to POEM as per the endoscopist at the time of endoscopic evaluation (example: esophageal stricture, malignancy).
- Any standard contraindication, including pregnancy, to anesthesia and/or colonoscopy
Key Trial Info
Start Date :
May 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06918730
Start Date
May 23 2025
End Date
February 28 2026
Last Update
January 5 2026
Active Locations (1)
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1
AdventHealth Orlando
Orlando, Florida, United States, 32804