PREcision MEDicine In Achalasia (PREMEDIA)
Recruiting
Phase 3
Interventional Study
Type I Achalasia
Type II Achalasia
EGJ Outflow Obstruction Without Spastic/Hypercontractile Features
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 372 (estimated)
- Sponsor
- Northwestern University · Other
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About This Trial
The goal of this clinical trial is to learn if shorter Per-Oral Endoscopic Myotomy (POEM) works as well as a longer POEM in patients with trouble swallowing due to certain conditions. The main question\[s\] it aims to answer \[is/are\]:
* Does making a smaller cut in the muscle at the bottom of the esophagus work just as well as making the standard bigger cut in relieving symptoms?
* Does making …
Trial Locations
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Eligibility Criteria
Inclusion Criteria
1. Age ≥ 18
2. Type I achalasia or type II achalasia or cEGJOO
3. Eckardt score \> 3
Exclusion Criteria
The following exclusion criteria are for the RCT, but 1-13 below also pertain to the observational study:
1. Prior POEM
2. Prior surgical treatment for achalasia
3. Endoscop…
Contacts