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RecruitingNCT07293689PREMEDIAUpdated Oct 13, 2026

PREcision MEDicine In Achalasia (PREMEDIA) - Cohort

An observational study in Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features and Jackhammer Esophagus, sponsored by Northwestern University. Recruiting at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Northwestern University · Observational

Updated Oct 13, 2026Site recruiting status changedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Type III Achalasia
  • EGJ Outflow Obstruction With Spastic/Hypercontractile Features
  • Jackhammer Esophagus
  • Distal Esophageal Spasm

Browse trials for

Keywords

  • achalasia
  • EGJOO
03

In context

Esophageal Achalasia

143 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.

This study's planned enrollment of 200 is above the median of 111 across 41 observational studies indexed under Esophageal Achalasia.

Browse Esophageal Achalasia studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.

Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Eligibility criteria

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 (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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: From Enrollment to Year 2

07

Study locations

9 of 16 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Aug 2031, 56 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2025
First posted
Dec 19, 2025
StartEst.
Dec 1, 2026
Primary completionEst.
Aug 31, 2031
CompletionEst.
Aug 31, 2032
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites changed recruiting status (2 now recruiting)
Show 2 sites
  • University of California San Diego · La Jolla, United StatesNot yet recruiting→Recruiting
  • Washington University · St Louis, United StatesNot yet recruiting→Recruiting
Oct 13, 2026
Site contacts
Changed at 2 sites. See the sites
Show 2 sites
  • University of California San Diego · La Jolla, United StatesContact added P•••@health.ucsd.edu · •••5236Contact added (no phone or email listed)
  • Washington University · St Louis, United StatesContact added P•••@wustl.edu · •••1432Contact added (no phone or email listed)
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    2 sites changed recruiting status (2 now recruiting)
    Show 2 sites
    • University of California San Diego · La Jolla, United StatesNot yet recruiting→Recruiting
    • Washington University · St Louis, United StatesNot yet recruiting→Recruiting
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • University of California San Diego · La Jolla, United StatesContact added P•••@health.ucsd.edu · •••5236Contact added (no phone or email listed)
    • Washington University · St Louis, United StatesContact added P•••@wustl.edu · •••1432Contact added (no phone or email listed)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07293689
Responsible party
John Pandolfino (PRINCIPAL INVESTIGATOR (Contact PI), Northwestern University) — Principal investigator
First posted
Dec 19, 2025
Start date
Dec 1, 2026 (estimated)
Primary completion
Aug 31, 2031 (estimated)
Completion
Aug 31, 2032 (estimated)
Last update
Oct 13, 2026

Study contacts

Elizabeth Yan, BS
Contact
premedia.dcc@northwestern.edu
312-908-1723
Yasmin Pina, BS
Contact
premedia.dcc@northwestern.edu
312-503-6459

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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