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Type I AchalasiaPhase 3PREMEDIANCT07293650

PREcision MEDicine In Achalasia (PREMEDIA)

A Phase 3 study testing Standard Myotomy and Tailored Short Myotomy in people with Type I Achalasia and Type II Achalasia, run by Northwestern University at 16 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if shorter Per-Oral Endoscopic Myotomy (POEM) works as well as a longer POEM in patients with trouble swallowing due to certain conditions. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Standard Myotomy and Tailored Short Myotomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
372 participants
Where
16 sitesUnited States
Study dates
29 Apr 2026to 1 Aug 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18
  • Type I achalasia or type II achalasia or cEGJOO
  • Eckardt score > 3

Who cannot join

  • The following exclusion criteria are for the RCT, but 1-13 below also pertain to the observational study:
  • Prior POEM
  • Prior surgical treatment for achalasia
  • Endoscopic pneumatic dilation or lower esophageal sphincter botulinum toxin (botox) injection within 6 months
  • Prior unrelated esophageal or upper gastric surgery, including Roux-en-Y gastric bypass and sleeve gastrectomy
  • Prior endoscopic gastroesophageal intervention for obesity or GERD, such endoscopic sleeve gastroplasty or transoral incisionless fundoplication
Show all 17Show fewer
  • Known secondary achalasia related to malignancy (pseudoachalasia)
  • Known eosinophilic esophagitis
  • Diverticulum (> 2 cm) in distal esophagus
  • Megaesophagus
  • Fibroinflammatory stricture of the esophagus due to any etiology (e.g., peptic, radiation, eosinophilic)
  • Pregnancy
  • Standard contraindications to general anesthesia
  • Standard contraindications to endoscopic myotomy in the esophagus (e.g. untreated varices)
  • Unwillingness or inability to consent for the study
  • Anticipated inability to follow protocol
  • Weekly (or more frequent) opioid medication use in the last 2 years

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

16 sites in 1 country

United States16 sites, 16 recruiting
  • Emory University

    Atlanta, Georgia, 30322

    Halley Fowler, Lead Study Coordinator, 404-778-3184, halley.fowler@emory.edu

    Anand Jain, MD

    Recruiting
  • Johns Hopkins University

    Baltimore, Maryland, 21218

    Not yet recruiting
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Madison Paylor, Lead Study Coordinator, 617-726-0196, premedia@mgb.org

    Kyle Staller, MD

    Recruiting
  • Atrium Health/Wake Forest

    Charlotte, North Carolina, 28204

    Greg Scarola, Lead Study Coordinator, (704) 355-2000, PREMEDIA@advocatehealth.org

    Badih Elmunzer, MD

    Recruiting
  • Northwestern University

    Chicago, Illinois, 60611

    Eric Pfannkuche, Lead Study Coordinator, 312-926-4525, PREMEDIA@northwestern.edu

    John Pandolfino, MD

    Recruiting
  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Not yet recruiting
  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

    Stephanie Baker, Lead Study Coordinator, 216-778-5736, premedia@metrohealth.org

    Ronnie Fass, MD

    Recruiting
  • Baylor Scott & White Health

    Dallas, Texas, 75204

    Not yet recruiting
  • University of Colorado Denver

    Denver, Colorado, 80217

    Not yet recruiting
  • University of Florida

    Gainesville, Florida, 32611

    April Goddard, Lead Study Coordinator, PA-C, 352-273-9483, DOM-GIResereachTeam@ad.ufl.edu

    Peter Draganov, MD

    Recruiting
  • University of California San Diego

    La Jolla, California, 92037

    Alexander Gonsalves, Lead Study Coordinator, 858-246-5236, PREMEDIA@health.ucsd.edu

    Rena Yadlapati, MD

    Recruiting
  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Larry Raber, Lead Study Coordinator, 615-322-4643, larry.w.raber@vumc.org

    Dhyanesh Patel, MD

    Recruiting
  • Weill Cornell Medical College

    New York, New York, 10065

    Not yet recruiting
  • Adventist Health System/Sunbelt, Inc

    Orlando, Florida, 32803

    Not yet recruiting
  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

    Not yet recruiting
  • Washington University

    St Louis, Missouri, 63110

    Darren Nix, Lead Study Coordinator, 314-273-1432, Premediasurgerytrial@wustl.edu

    Chandra Gyawali, MD

    Recruiting

Other trials in United States

About this study

Official title: PREcision MEDicine In Achalasia - A Multicenter Randomized Non-Inferiority Clinical Trial of Short Tailored POEM vs. Standard POEM for Non-Spastic Achalasia and A Multicenter Prospective Cohort Study of Long Tailored POEM for Spastic Esophageal Motility Disorders

The goal of this clinical trial is to learn if shorter Per-Oral Endoscopic Myotomy (POEM) works as well as a longer POEM in patients with trouble swallowing due to certain conditions. The main question[s] it aims to answer [is/are]:

  • Does making a smaller cut in the muscle at the bottom of the esophagus work just as well as making the standard bigger cut in relieving symptoms?
  • Does making the smaller cut reduce the side effects of the procedure compared to the standard bigger cut? Researchers will compare the symptoms and side effects of making a shorter cut to the symptoms and side effects of a longer cut.

Participants will allow researchers to access their standard of care information in their medical record, complete questionnaires at up to 6 times over a 2-year period.

Read the detailed description

The investigators will perform a randomized controlled trial to compare two different approaches to Peroral Endoscopic Myotomy (POEM) for treating achalasia (Types I and II) and esophagogastric junction outflow obstruction (EGJOO). The most widely used treatment for achalasia is POEM but the current approach involves a 9 cm (3.5 inch) myotomy (cutting of the muscle) to open up the tight lower esophageal sphincter to promote food delivery from the esophagus to the stomach. This approach is very effective, with success rates of approximately 90% over the short term. However, the investigators believe that POEM does not require a full 9 cm myotomy and that the investigators can cut much less muscle (approximately 4cm/1.25inches) to achieve similar improvement in symptoms but with less long-term complications. Cutting less muscle may result in less acid reflux, which is the Achilles heel of any successful treatment for achalasia. A shorter muscle cut may also result in less of a complication known as blown-out myotomy, which causes failure of the esophagus to empty its contents and is a major cause of long-term symptom relapse. The investigators have designed this study to determine whether the shorter myotomy (4 cm) is equivalent to the longer myotomy (9 cm) in terms if symptom improvement, but with the possibility of less acid reflux and blown-out myotomy.

Given these questions, the investigators will enroll 370 patients in a randomized trial where patients will receive either the short tailored (4cm/1.25 inches) or the standard myotomy (9cm/3.5 inches). All patients will undergo intraoperative assessment of success of the myotomy by using a special tool called the functional lumen imaging probe (FLIP). The FLIP will measure the opening dimensions of the lower esophageal sphincter and ensure that the myotomy is adequately performed so that the lower esophageal sphincter can open to a level that will improve esophageal emptying/swallowing. The investigators will follow patients for 2 years in a manner similar to how the investigators would follow patients after achalasia treatment in standard clinical practice. The investigators will assess whether symptoms are similar and whether or not there are differences in acid reflux and esophageal emptying. Patients will undergo follow up testing with questionnaires at intervals of 3-6 months over two years and they will have reflux testing (measure acid exposure using a capsule placed during endoscopy) between 6-12 months and a barium esophagram (X ray while drinking barium) at 2 years. The most important aim is to prove that the symptoms and outcomes success/failure) between the two approaches are similar (short myotomy is non-inferior) and the Eckardt score will be the primary questionnaire score for this study. The investigators believe that this study will help define the optimal approach to POEM in achalasia and also help us prevent complications in the future.

Additionally, the investigators will also ask participants to provide a sample of the muscle tissue that is typically cut during the POEM. This tissue will help us develop a tissue bank to help other researchers looking into the causes of why achalasia and these other esophageal diseases occur. The participants can opt out of this part and still continue in the randomized controlled trial.

Being tested
Standard Myotomy, Tailored Short Myotomy
Keywords
achalasia, EGJOO
Medical subject headings
Esophageal Achalasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard MyotomyProcedure or surgery

    Myotomy during POEM of 8-10 cm in length, extending 2-3 cm into the gastric cardia; intention to perform selective circular myotomy, but allowing full thickness myotomy. FLIP is used to confirm adequate myotomy.

  • Tailored Short MyotomyProcedure or surgery

    Myotomy during POEM of 4-5 cm in length, extending 1-2 cm into the gastric cardia; intend to perform selective circular myotomy, but allowing full thickness myotomy. FLIP is used to confirm adequate myotomy.

Study groups in NCT07293650
Study groupRoleWhat they receive
Standard MyotomyActive comparatorNot described
Receives: Procedure: Standard Myotomy
Tailored Short MyotomyExperimentalNot described
Receives: Procedure: Tailored Short Myotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Response-Overall

    Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years.

    Measured: From enrollment to Year 2

  2. Clinical Response-by Sex

    Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years.

    Measured: From enrollment to Year 2

  3. Clinical Response-by Race

    Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years.

    Measured: From Enrollment to Year 2

  4. Clinical Response-by Ethnicity

    Clinical Response is defined by the Eckardt score (a 4-item self-report scale measuring weight loss, chest pain, regurgitation, and dysphagia) with no need for retreatment in 2 years.

    Measured: From Enrollment to Year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2025
  2. Study start29 Apr 2026
  3. Primary completionAug 2031 (estimated)
  4. Study completion1 Aug 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
372 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07293650
Sponsor's protocol ID
PREMEDIA (Pro00083748) - 01
Acronym
PREMEDIA
Status last verified
Oct 2026
First submitted
17 Dec 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Standard Myotomy and Tailored Short Myotomy in people with Type I Achalasia and Type II Achalasia, run by Northwestern University at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elizabeth Yan, BS (312-908-1723, premedia.dcc@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Response-Overall (time frame: From enrollment to Year 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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