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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

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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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Interested in participating?

Recruiting

Interested in participating?

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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
Aug 28, 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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