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NCT03228758 · ClinicalTrials.gov registry record · NA
Anterior Orientation vs Posterior Orientation in Per Oral Endoscopic Myotomy POEM for the Treatment of Achalasia
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 89
- Enrollment target
NCT03228758: Completed NA study, sponsored by NYU Langone Health.
NCT03228758 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 89 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03228758, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 89 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety and efficacy of the anterior versus posterior myotomy technique in Per Oral Endoscopic Myotomy (POEM) for the treatment of Achalasia. The primary efficacy outcome is periprocedural pain requiring the use of narcotics. The secondary outcomes focus on safety which includes technical procedure duration time; tunneling time, myotomy time, and closure time; incidence of mucosotomy (transmural and non-transmural injury), capnoperitoneum, and the postoperative sequelae of gastrointestinal reflux disease (GERD). Periprocedural pain data collection will include post POEM procedure pain scores, administrations of analgesia until discharge. The final analysis will focus on determining whether there is a statistically significant difference in the amount and severity of pain in the Anterior versus Posterior myotomy subject populations. Additional analysis will be the collection of analgesic type (narcotic versus non-narcotic), dosage, frequency, and duration of treatment from post POEM procedure in the endoscopy recovery suite until the subjects are discharged.
Primary Outcome
Pain related to the endoscopic myotomy requiring the use of narcotic pain medication.
Interventions
- PROCEDURE Per Oral Endoscopic Myotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2017-07-24 |
| Est. Completion | 2019-05-24 |
| Phase | NA |
What the finished NCT03228758 record still lists
NCT03228758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Per Oral Endoscopic Myotomy is the first listed.
NCT03228758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03228758 about?
NCT03228758 is a clinical study titled "Anterior Orientation vs Posterior Orientation in Per Oral Endoscopic Myotomy POEM for the Treatment of Achalasia". The purpose of this study is to compare the safety and efficacy of the anterior versus posterior myotomy technique in Per Oral Endoscopic Myotomy (POEM) for the treatment of Achalasia. The primary efficacy outcome is periprocedural pain requiring the use of narcotics. The secondary outcomes focus on...
What is the current status of trial NCT03228758?
This trial is currently completed. It is a NA study. The enrollment target is 89 participants. The study started on 2017-07-24. Estimated completion is 2019-05-24.
What interventions are being tested in trial NCT03228758?
The interventions under investigation include: Per Oral Endoscopic Myotomy (PROCEDURE).
Who is sponsoring clinical trial NCT03228758?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03228758's enrollment target sits among peer trials
89 972nd of 2000 higher than 1,029 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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