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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 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 89 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03228758
The ClinicalTrials.gov registry entry for NCT03228758 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Per Oral Endoscopic Myotomy is the first listed.
NCT03228758 reports 0 study locations.
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.
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