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Tailored muscle cuts for swallowing disorders: a precision medicine trial

NCT ID NCT07293689

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 28, 2026 · Updated 9 times

Summary

This study observes how doctors decide the length of the muscle cut during POEM surgery for people with swallowing disorders like achalasia. Researchers will follow 200 adults for 2 years, tracking symptoms and whether retreatment is needed. The goal is to see if tailoring the surgery to each patient's condition leads to better outcomes.

What this could mean

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

What this could lead to
If successful, this could show that tailoring the length of the muscle cut during POEM surgery leads to better, more personalized treatment for swallowing disorders.
What could go wrong
This is an observational study, not a test of a new treatment. It only looks at how doctors currently decide, so it won't prove that one method is better than another.

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.

Participants

About 200 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

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.

Who is studied

Achalasia, EGJOO, and other spastic motility disorders are relatively rare and have substantial quality of life implications (see Protocol and Research Strategy for details). Given the prevalence and severity of these conditions, it is uncommon for patients with symptoms to not seek some form of treatment. Thus, we expect much of the recruitment to occur directly from site clinics, which include prominent esophageal motility experts and have robust referral networks, as patients seek care. A review of POEM procedure logs from participating CCs reveals that likely eligible patients are on average about 55-65 years old. We anticipate that the ethnic and racial distribution of our study group will be similar to prior achalasia studies with 25% African American, 10% Hispanic and 65% Caucasian.

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 III achalasia or EGJOO with spastic/hypercontractile features or Jackhammer Esophagus or Distal Esophageal Spasm 3. Eckardt Score \> 3 Exclusion Criteria: * Exclusion: 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

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Conditions

The condition(s) this trial relates to.

achalasia dyskinesia of esophagus Esophageal Achalasia idiopathic achalasia

As listed by the trial registrant

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

Distal esophageal spasm Egj outflow obstruction with spastic/hypercontractile features Jackhammer esophagus Type III 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

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