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Smaller incision, same relief? new trial tests less invasive POEM for achalasia

NCT ID NCT07293650

Symptom relief Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 8 times

Summary

This study compares a shorter muscle cut (4-5 cm) during a procedure called POEM to the standard longer cut (8-10 cm) for people with certain swallowing disorders. The goal is to see if the shorter cut works just as well at relieving symptoms like trouble swallowing and chest pain, while possibly causing fewer side effects. About 372 adults with type I or II achalasia or related conditions will participate and be followed for two years.

What this could mean

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

Active substance
Per-Oral Endoscopic Myotomy (POEM) procedure
What this could lead to
If successful, this could mean a less invasive, safer procedure for people with swallowing disorders, reducing side effects while maintaining symptom relief.
What could go wrong
This is a Phase 3 trial, but it's still possible the shorter cut won't work as well as the standard one, or that benefits vary by patient. Side effects like reflux may still occur.

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 372 people

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

Started

Apr 2026

Expected to finish

Aug 2032

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 1. Age ≥ 18 2. Type I achalasia or type II achalasia or cEGJOO 3. Eckardt score \> 3 Exclusion Criteria The following exclusion criteria are for the RCT, but 1-13 below also pertain to the observational study: 1. Prior POEM 2. Prior surgical treatment for achalasia 3. Endoscopic pneumatic dilation or lower esophageal sphincter botulinum toxin (botox) injection within 6 months 4. Prior unrelated esophageal or upper gastric surgery, including Roux-en-Y gastric bypass and sleeve gastrectomy 5. Prior endoscopic gastroesophageal intervention for obesity or GERD, such endoscopic sleeve gastroplasty or transoral incisionless fundoplication 6. Known secondary achalasia related to malignancy (pseudoachalasia) 7. Known eosinophilic esophagitis 8. Diverticulum (\> 2 cm) in distal esophagus 9. Megaesophagus 10. Fibroinflammatory stricture of the esophagus due to any etiology (e.g., peptic, radiation, eosinophilic) 11. Pregnancy 12. Standard contraindications to general anesthesia 13. Standard contraindications to endoscopic myotomy in the esophagus (e.g. untreated varices) 14. Unwillingness or inability to consent for the study 15. Anticipated inability to follow protocol 16. Weekly (or more frequent) opioid medication use in the last 2 years

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Conditions

The condition(s) this trial relates to.

achalasia Esophageal Achalasia idiopathic achalasia

As listed by the trial registrant

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

Egj outflow obstruction without spastic/hypercontractile features Type I achalasia Type II achalasia

How to take part

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

  1. The places running it

    16 sites. 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

  • Adventist Health System/Sunbelt, Inc

    NOT_YET_RECRUITING

    Orlando, Florida, 32803, United States

  • Atrium Health/Wake Forest

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Baylor Scott & White Health

    NOT_YET_RECRUITING

    Dallas, Texas, 75204, United States

  • Case Western Reserve University

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44106, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Johns Hopkins University

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21218, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Arizona

    NOT_YET_RECRUITING

    Scottsdale, Arizona, 85259, United States

  • MetroHealth Medical Center

    RECRUITING

    Cleveland, Ohio, 44109, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • University of California San Diego

    NOT_YET_RECRUITING

    La Jolla, California, 92093, United States

  • University of Colorado Denver

    NOT_YET_RECRUITING

    Denver, Colorado, 80217, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32611, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University

    NOT_YET_RECRUITING

    St Louis, Missouri, 63130, United States

  • Weill Cornell Medical College

    NOT_YET_RECRUITING

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.