Transverse vs Longitudinal Mucosal Incision During POEM

February 20, 2026 updated by: Juan Pablo Alzate, Universidad Nacional de Colombia

Transverse Versus Longitudinal Mucosal Incision in Peroral Endoscopic Myotomy: A Multicenter Randomized Clinical Trial

Peroral endoscopic myotomy (POEM) is a minimally invasive endoscopic procedure used to treat achalasia and other spastic esophageal motility disorders. A key step in POEM is creating a small opening in the esophageal lining (mucosal incision) to enter the submucosal tunnel. This study evaluates whether making that entry incision **transverse** (across the esophagus) versus **longitudinal** (along the esophagus) improves procedural efficiency without reducing safety.

This is a **multicenter, randomized (1:1), parallel-group clinical trial** conducted in three therapeutic endoscopy units in Colombia (Hospital Universitario del Valle and Clínica Versalles in Cali, and Clínica del Occidente in Bogotá). Adults (≥18 years) with an indication for POEM, ASA I-III, and ability to provide informed consent will be eligible; key exclusions include prior myotomy/major esophageal surgery, uncorrectable coagulopathy, pregnancy, active systemic infection, anesthesia contraindication, or anticipated technical inability to perform POEM.

All procedures are standardized: POEM under **general anesthesia with orotracheal intubation**, **CO₂ insufflation**, validated endoscopic knives and preset electrosurgical modes; hemostasis with **Coagrasper® only if needed**; and closure using standard **through-the-scope (TTS) clips**. Participants are randomly assigned to a **15 mm transverse mucosal incision** (perpendicular to the esophageal axis) or a **15 mm longitudinal mucosal incision**. Full-procedure video is recorded for quality control and to allow objective timing, with blinded assessment of the primary outcome.

The **primary outcome** is the time (seconds) from the first mucosal cut to successful entry of the endoscope cap into the submucosal tunnel (advancing at least 1 cm). **Secondary outcomes** include need for hemostasis with Coagrasper®, number of clips required for complete closure, and early complications (including perforation and gas-related events such as capnoperitoneum requiring decompression and emphysema), monitored through **30 days**.

Participants complete a screening/preoperative visit (up to 30 days before), undergo the POEM procedure, have early in-hospital/discharge assessment (days 1-2), and receive safety follow-up contacts at approximately 1 week and day 30.

Risks are those expected from standard POEM and peri-anesthesia care (e.g., bleeding, perforation, infection, and gas-related complications), and participants may not directly benefit clinically. However, the transverse incision may shorten access and closure time and reduce resource use without increasing short-term complications.

The study will be conducted with written informed consent, confidentiality protections (pseudonymization and secure storage), and reporting of results in aggregate form.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosis of achalasia or other spastic esophageal motility disorders with an indication for POEM
  • ASA physical status I-III
  • Ability to provide informed consent

Exclusion Criteria:

  • Prior myotomy or major esophageal surgery
  • Uncorrectable coagulopathy
  • Pregnancy
  • Active systemic infection
  • Contraindication to anesthesia
  • Any situation predicting technical inability to perform POEM

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transverse Mucosal Incision During POEM
POEM performed with a 15 mm transverse mucosal incision (perpendicular to the esophageal axis) for entry into the submucosal tunnel, under a standardized POEM protocol (general anesthesia with orotracheal intubation, CO₂ insufflation, validated endoscopic knives/electrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded)
Procedure: Transverse Mucosal Incision During POEM
POEM performed with a 15 mm transverse mucosal incision (perpendicular to the esophageal axis) for entry into the submucosal tunnel, under a standardized POEM protocol (general anesthesia with orotracheal intubation, CO₂ insufflation, validated endoscopic knives/electrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded).
Active Comparator: Longitudinal Mucosal Incision During POEM
POEM performed with a 15 mm longitudinal mucosal incision (parallel to the esophageal axis) for entry into the submucosal tunnel, under the same standardized POEM protocol (general anesthesia with orotracheal intubation, CO₂ insufflation, validated endoscopic knives/electrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded)
Procedure: Longitudinal Mucosal Incision During POEM
POEM performed with a 15 mm longitudinal mucosal incision (parallel to the esophageal axis) for entry into the submucosal tunnel, under the same standardized POEM protocol (general anesthesia with orotracheal intubation, CO₂ insufflation, validated endoscopic knives/electrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Effective Submucosal Tunnel Entry (Seconds)
Time Frame: During the POEM procedure (Day 0; intraoperative)
Time (in seconds) from the first mucosal cut to effective entry of the endoscope cap into the submucosal tunnel, defined as allowing advancement of at least 1 cm.
During the POEM procedure (Day 0; intraoperative)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bleeding Requiring Hemostasis With Coagrasper®
Time Frame: During the POEM procedure (Day 0; intraoperative)
Proportion of procedures with bleeding that requires hemostasis using Coagrasper® (Yes/No).
During the POEM procedure (Day 0; intraoperative)
Procedure-Related Complications (Up to 30 Days)
Time Frame: Up to 30 days after the procedure (contacts at ~1 week and Day 30; plus early assessment Days 1-2).
Any complication related to the procedure, monitored through 30 days.
Up to 30 days after the procedure (contacts at ~1 week and Day 30; plus early assessment Days 1-2).

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Nacional de Colombia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital San Rafael de Facatativá

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 2, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DE-F-254-V8

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

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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Conditions

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Dietary Supplements

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