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Cutting across or along? trial tests best way to start POEM for swallowing disorder

NCT ID NCT07425977

Symptom relief Sponsor: Universidad Nacional de Colombia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests whether making a horizontal (transverse) or vertical (longitudinal) cut in the esophagus lining during POEM surgery is faster and safer for people with achalasia, a swallowing disorder. About 140 adults in Colombia will be randomly assigned to one of the two incision types. The main goal is to see how quickly the surgeon can enter the tunnel under the lining, and they will also track complications like bleeding or gas issues for up to 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
procedure: peroral endoscopic myotomy (POEM) with either transverse or longitudinal mucosal incision
What this could lead to
If successful, this could show that a transverse incision makes the POEM procedure faster and safer for treating achalasia.
What could go wrong
This is a small, early-phase trial with only 140 participants. The results may not apply to all patients, and the procedure carries standard risks like bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

achalasia dyskinesia of esophagus Esophageal Achalasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal achalasia Spastic esophageal motility disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alzate

    Bogotá, Colombia

More trials for these conditions

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