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NCT06918730 · ClinicalTrials.gov registry record · NA
U-POEM vs CO2-POEM
A NA study of Esophageal Motility Disorders, sponsored by AdventHealth.
- Active
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06918730 is a NA study of Esophageal Motility Disorders that is active but no longer recruiting, run by AdventHealth. The registered enrollment target is 36 participants, below the 85-participant average among 3 other Esophageal Motility Disorders trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06918730, a NA study of Esophageal Motility Disorders, is active but no longer recruiting, sponsored by AdventHealth.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study 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 routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air, which has been shown to reduce gas-related complications. Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation has been shown to be associated with improved patient satisfaction, safety profile and even higher detection of polyps during colonoscopy in randomized trials Aim 1. The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM. Aim 2. Compare the proportion of patients that require post-procedural admission for pain management. Aim 3. Compare the need for analgesic medications for pain control in patients undergoing U-POEM vs. CO2-POEM. Aim 4. Compare technical and clinical success between U-POEM vs. CO2-POEM. Technical success is defined as successful completion of the procedure whereas clinical success will be defined as an Eckardt score ≤ 3 at the time of follow-up. Aim 5. Compare and evaluate procedural characteristics between the two groups. 1. Compare procedural time between U-POEM and CO2-POEM. 2. Compare the mean number of coagulations with hemostatic forceps for active intraprocedural bleeding and the mean number of times in which a device besides an electrosurgical knife was required for prophylactic ablation of vessels. 3. Adverse event rate (i.e. bleeding, perforation).
Conditions Studied
Interventions
- PROCEDURE U-POEM
- PROCEDURE CO2-POEM
Study Locations (1)
Florida
- AdventHealth Orlando - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-05-23 |
| Est. Completion | 2026-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06918730
The ClinicalTrials.gov registry entry for NCT06918730 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 85-participant average among 3 other Esophageal Motility Disorders trials with a reported enrollment target (58% lower). The listed sponsor is AdventHealth, which has 95 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Esophageal Motility Disorders appearing as the primary indexed condition, and to 2 interventions - of which U-POEM is the first listed.
NCT06918730 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT06918730 about?
NCT06918730 is a clinical study titled "U-POEM vs CO2-POEM". 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 routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbe...
What is the current status of trial NCT06918730?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2025-05-23. Estimated completion is 2026-02-28.
What conditions does trial NCT06918730 study?
This clinical trial studies the following conditions: Esophageal Motility Disorders.
What interventions are being tested in trial NCT06918730?
The interventions under investigation include: U-POEM (PROCEDURE), CO2-POEM (PROCEDURE).
Who is sponsoring clinical trial NCT06918730?
This trial is sponsored by AdventHealth, which has 95 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06918730 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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