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NCT Number: NCT07293689

PREcision MEDicine In Achalasia (PREMEDIA) - Cohort

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.

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Key information

Conditions

Type III Achalasia Deglutition Disorders Digestive System Diseases Distal Esophageal Spasm EGJ Outflow Obstruction With Spastic/Hypercontractile Features Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Jackhammer Esophagus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Arizona, Scottsdale, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18
Type III achalasia or EGJOO with spastic/hypercontractile features or Jackhammer Esophagus or Distal Esophageal Spasm
Eckardt Score > 3

Exclusion criteria

Exclusion:

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)
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

Treatment and study plan

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Yan, BS

CONTACT

[email protected]

312-908-1723

Yasmin Pina, BS

CONTACT

[email protected]

312-503-6459

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study 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

Acronym: PREMEDIA

Important dates

Study start: 2026
Primary completion: 2031
Study completion: 2032
First posted: Dec 19, 2025
Registry last updated: Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting