NCT07293689 PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
| NCT ID | NCT07293689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Type III Achalasia |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2026-06-01 with a primary completion date of 2029-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 malignancy (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 contraindications 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07293689 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type III Achalasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07293689 currently recruiting?
Yes, NCT07293689 is actively recruiting participants. Contact the research team at elizabeth.yan@northwestern.edu for enrollment information.
Where is the NCT07293689 trial being conducted?
This trial is being conducted at Scottsdale, United States, La Jolla, United States, Denver, United States, Gainesville, United States and 9 additional locations.
Who is sponsoring the NCT07293689 clinical trial?
NCT07293689 is sponsored by Northwestern University. The trial plans to enroll 200 participants.