Type III AchalasiaPREMEDIANCT07293689
PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
An observational study of Type III Achalasia and EGJ Outflow Obstruction With Spastic/Hypercontractile Features, run by Northwestern University at 16 sites in United States.
Trial summary
The goal of this observational study is to learn about how the doctor decides how long to cut t the esophageal muscle during Per-Oral Endoscopic Myotomy (POEM) in patients with difficulty 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 III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features, Jackhammer Esophagus
- How many people
- 200 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Dec 2026to 31 Aug 2032
- Phase
- Observational
- 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
Study population: 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.
Who may be able to join
- Age ≥ 18
- Type III achalasia or EGJOO with spastic/hypercontractile features or Jackhammer Esophagus or Distal Esophageal Spasm
- Eckardt Score > 3
Who cannot join
- 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
- Known secondary achalasia related to malignancy (pseudoachalasia)
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- 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
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 observational study is to learn about how the doctor decides how long to cut t the esophageal muscle during Per-Oral Endoscopic Myotomy (POEM) in patients with difficulty swallowing due to certain conditions. The main question it aims to answer is: does pre-POEM testing help the physician choose how long to cut the muscle.
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.
- Conditions
- Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features, Jackhammer Esophagus, Distal Esophageal Spasm
- Keywords
- achalasia, EGJOO
- Medical subject headings
- Esophageal Achalasia
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 start1 Dec 2026 (estimated)
- Primary completion31 Aug 2031 (estimated)
- Study completion31 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 III 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 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
- NCT07293689
- Sponsor's protocol ID
- PREMEDIA (Pro00083748) - 02
- 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
- NCT07293689
- Acronym / sponsor ID
- PREMEDIA / PREMEDIA (Pro00083748) - 02
- Conditions
- Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features, Jackhammer Esophagus, Distal Esophageal Spasm
- Keywords
- achalasia, EGJOO
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Aug 2031 (estimated)
- Study completion
- 31 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 observational study is to learn about how the doctor decides how long to cut t the esophageal muscle during Per-Oral Endoscopic Myotomy (POEM) in patients with difficulty swallowing due to certain conditions. The main question it aims to answer is: does pre-POEM testing help the physician choose how long to cut the muscle.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18
- Type III achalasia or EGJOO with spastic/hypercontractile features or Jackhammer Esophagus or Distal Esophageal Spasm
- Eckardt Score > 3
Key exclusion criteria (15 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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?
An observational study of Type III Achalasia and EGJ Outflow Obstruction With Spastic/Hypercontractile Features, 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 15 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.
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.