U-POEM vs CO2-POEM

NCT06918730 | Active Not Recruiting DMC

• 1 other identifier: 2263975
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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. 1.Compare procedural time between U-POEM and CO2-POEM.
2. 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. 3.Adverse event rate (i.e. bleeding, perforation).

Conditions

Esophageal Motility Disorders

Keywords

POEM; U-POEM; CO2-POEM; Esophageal motility

Outcome Measures

Primary Outcomes (2)

• Pain measurement outcomes post procedure: Numeric Pain Scale

  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

  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 Outcomes (4)

• Readmission rate

  30 days post procedure (+- 7 days)

• Analgesic medication needs

  30 days post procedure (+- 7 days)

• Compare technical success between POEM procedures

  up to 6 months

• Compare technical success between POEM procedures

  up to 6 months

Study Arms (2)

CO2-POEM

EXPERIMENTAL

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

Procedure: CO2-POEM

U-POEM

EXPERIMENTAL

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

Procedure: U-POEM

Interventions

U-POEM PROCEDURE

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

U-POEM

CO2-POEM PROCEDURE

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

CO2-POEM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AdventHealth: lead
• Mayo Clinic: collaborator
• University of South Florida: collaborator

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Related Publications (22)

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MeSH Terms

Conditions

Esophageal Motility Disorders

Condition Hierarchy (Ancestors)

Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Dennis Yang, MD

  AdventHealth Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 9, 2025
• Study Start: May 23, 2025
• Primary Completion: October 30, 2025
• Study Completion: February 28, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)