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NCT04798547 · ClinicalTrials.gov registry record · NA
Short Vs Standard Length Myotomy in Achalasia
A NA study of Achalasia, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04798547: Completed NA study of Achalasia, sponsored by Northwestern University.
NCT04798547 is a NA study of Achalasia that has completed, run by Northwestern University. The registered enrollment target is 60 participants, below the 133-participant average among 7 other Achalasia trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04798547, a NA study of Achalasia, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this randomized controlled trial (non-inferiority study) is to evaluate the outcomes of 4 cm short myotomy compared to the 8 cm standard length myotomy in Per-Oral Endoscopic Myotomy (POEM) for patients with achalasia. We hypothesize that a shorter myotomy with POEM will have the same clinical efficacy as standard length myotomy based on patient-reported Eckardt score with shorter procedure times and reduced complications.
Primary Outcome
At 1, 6 and 12 months, patient reported outcome of achalasia symptoms will be assessed. The Eckardt Score is a validated research tool for achalasia symptoms. Scores range from 0-12. A higher score indicates worse symptoms. We will compare Eckardt Score pre-POEM and post-PEM at various time points.
Conditions Studied
Interventions
- PROCEDURE Short Myotomy
- PROCEDURE Standard Length Myotomy
Study Locations (1)
Illinois
- Northwestern Memorial Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2024-02-29 |
| Phase | NA |
What the finished NCT04798547 record still lists
NCT04798547 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 7 other Achalasia trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Achalasia appearing as the primary indexed condition, and to 2 interventions - of which Short Myotomy is the first listed.
NCT04798547 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04798547 about?
NCT04798547 is a clinical study titled "Short Vs Standard Length Myotomy in Achalasia". The objective of this randomized controlled trial (non-inferiority study) is to evaluate the outcomes of 4 cm short myotomy compared to the 8 cm standard length myotomy in Per-Oral Endoscopic Myotomy (POEM) for patients with achalasia. We hypothesize that a shorter myotomy with POEM will have the sa...
What is the current status of trial NCT04798547?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2020-06-01. Estimated completion is 2024-02-29.
What conditions does trial NCT04798547 study?
This clinical trial studies the following conditions: Achalasia.
What interventions are being tested in trial NCT04798547?
The interventions under investigation include: Short Myotomy (PROCEDURE), Standard Length Myotomy (PROCEDURE).
Who is sponsoring clinical trial NCT04798547?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04798547 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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