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.
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
- Conditions the study is for
- Type I Achalasia, Type II Achalasia, EGJ Outflow Obstruction Without Spastic/Hypercontractile Features
- 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
- Recruiting
Emory University
Atlanta, Georgia, 30322
Halley Fowler, Lead Study Coordinator, 404-778-3184, halley.fowler@emory.edu
Anand Jain, MD
- Not yet recruiting
Johns Hopkins University
Baltimore, Maryland, 21218
- 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
- Not yet recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
- Recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44109
Stephanie Baker, Lead Study Coordinator, 216-778-5736, premedia@metrohealth.org
Ronnie Fass, MD
- Not yet recruiting
Baylor Scott & White Health
Dallas, Texas, 75204
- Not yet recruiting
University of Colorado Denver
Denver, Colorado, 80217
- 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
- Not yet 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
- Recruiting
Washington University
St Louis, Missouri, 63110
Darren Nix, Lead Study Coordinator, 314-273-1432, Premediasurgerytrial@wustl.edu
Chandra Gyawali, MD
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.
- Conditions
- Type I Achalasia, Type II Achalasia, EGJ Outflow Obstruction Without Spastic/Hypercontractile Features
- 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 group | Role | What they receive |
|---|---|---|
| Standard Myotomy | Active comparator | Not described Receives: Procedure: Standard Myotomy |
| Tailored Short Myotomy | Experimental | Not described Receives: Procedure: Tailored Short Myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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.
- First posted19 Dec 2025
- Study start29 Apr 2026
- Primary completionAug 2031 (estimated)
- Study completion1 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I AchalasiaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Pandolfino, Northwestern University
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07293650
- Acronym / sponsor ID
- PREMEDIA / PREMEDIA (Pro00083748) - 01
- Conditions
- Type I Achalasia, Type II Achalasia, EGJ Outflow Obstruction Without Spastic/Hypercontractile Features
- Keywords
- achalasia, EGJOO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- 1 Aug 2032 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Myotomy | Active comparator | Procedure: Standard Myotomy |
| Tailored Short Myotomy | Experimental | Procedure: Tailored Short Myotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18
- Type I achalasia or type II achalasia or cEGJOO
- Eckardt score > 3
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard MyotomyMyotomy 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. | Procedure or surgery | Standard Myotomy |
| Tailored Short MyotomyMyotomy 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. | Procedure or surgery | Tailored Short Myotomy |
Primary outcome
Clinical Response-Overall
Time frame: From enrollment to Year 2
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.
Clinical Response-by Sex
Time frame: From enrollment to Year 2
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.
Clinical Response-by Race
Time frame: From Enrollment to Year 2
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.
Clinical Response-by Ethnicity
Time frame: From Enrollment to Year 2
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
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.