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U-POEM vs CO2-POEM

NCT06918730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-05-15

No results posted yet for this 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

  • Esophageal Motility Disorders

Interventions

PROCEDURE

U-POEM

Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation

PROCEDURE

CO2-POEM

POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • University of South Florida

    collaborator OTHER

  • AdventHealth

    lead OTHER

Principal Investigators

  • Dennis Yang, MD · AdventHealth Medical Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2025-10-30
Completion
2026-03-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06918730 on ClinicalTrials.gov