U-POEM vs CO2-POEM (U-POEM)

May 13, 2026 updated by: AdventHealth

Prospective Randomized Controlled Trial (RCT)Comparing Clinical Outcomes Between Underwater Versus Carbon Dioxide Insufflation During Peroral Endoscopic Myotomy (U-POEM Trial)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth Orlando

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • Ability to provide informed consent
  • Patient scheduled to undergo POEM procedure for esophageal dysmotility

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CO2-POEM
POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air.
Procedure: CO2-POEM
POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air.
Experimental: U-POEM
Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation
Procedure: U-POEM
Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain measurement outcomes post procedure: Numeric Pain Scale
Time Frame: Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)

The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM.

Using Numeric Pain Scale (NPS)

NPS is a numeric scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)
Pain measurement outcomes post procedure: Pain Quality Assessment Scale
Time Frame: Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)

The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM.

Pain Quality Assessment Scale (PQAS).

PQAS is a numeric scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission rate
Time Frame: 30 days post procedure (+- 7 days)
Compare the proportion of patients that require post-procedural admission for pain management.
30 days post procedure (+- 7 days)
Analgesic medication needs
Time Frame: 30 days post procedure (+- 7 days)
Compare the need for analgesic medications for pain control in patients undergoing U-POEM vs. CO2-POEM through electronic medical records.
30 days post procedure (+- 7 days)
Compare technical success between POEM procedures
Time Frame: up to 6 months

Compare clinical success between U-POEM vs. CO2-POEM. Clinical success will be defined as an Eckardt score ≤ 3 at the time of follow-up.

Achalasia Severity is measured by the Eckardt Score which consists of 4 questions used to characterize the severity of achalasia.

The questions include symptoms related to:

  • Dysphagia
  • Chest pain
  • Regurgitation
  • Weight loss.

Each question is assigned a score from 0 to 3 based on the patient's self-reported response.

The overall score ranges from 0-12, with anything less than 3 meaning no active symptoms, and anything higher than a 3 suggestive of active symptoms.
up to 6 months
Compare technical success between POEM procedures
Time Frame: up to 6 months
Compare technical success between U-POEM vs. CO2-POEM. Technical success is defined as successful completion of the procedure.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Collaborators

Mayo Clinic
University of South Florida

Investigators

  • Principal Investigator: Dennis Yang, MD, AdventHealth Medical Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2025

Primary Completion (Actual)

October 30, 2025

Study Completion (Actual)

March 3, 2026

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2263975

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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