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NCT02314741 · ClinicalTrials.gov registry record · NA
Peroral Endoscopic Myotomy (POEM) for Esophageal Motility
A NA study of Achalasia, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02314741: Completed NA study of Achalasia, sponsored by University of Pennsylvania.
NCT02314741 is a NA study of Achalasia that has completed, run by University of Pennsylvania. The registered enrollment target is 10 participants, below the 140-participant average among 7 other Achalasia trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02314741, a NA study of Achalasia, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators wish to monitor the adoption of a new, incisionless approach to performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally providing similar if not better outcomes (safety and efficacy) as the Heller myotomy. The investigators hope to enroll 10 patients with a clinical diagnosis of achalasia who meet inclusion criteria. The POEM procedure has been done in many hospitals without any research associated with it. Dr. Ginsberg, Dr. Chandrasekhara and Dr. Kochman will perform the procedures after being trained. Dr. Ginsberg has personally witnessed the performance of 10 POEM procedures and has performed in a swine model. The PI is credentialed to initiate POEM at HUP with the first case to be proctored by an experienced operator. The PI will then proctor the other adopters. The investigators would like to evaluate the safety of it and the effectiveness of it. The investigators will use their symptom scores and radiology tests pre- and post-POEM to evaluate effectiveness.
Primary Outcome
The primary aim of this study is to assess safety and efficacy in the adoption of the POEM procedure compared to the typical Heller Myotomy used for the treatment of achalasia using standardized methods, including esophageal manometry, pre- and post- procedure barium swallow studies, as well as standardized measures of dysphagia symptoms due to achalasia (the Eckart score), and patient's medical records and self-reported symptoms.
Conditions Studied
Interventions
- PROCEDURE POEM Procedure
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-05 |
| Phase | NA |
What the finished NCT02314741 record still lists
NCT02314741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 140-participant average among 7 other Achalasia trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Achalasia appearing as the primary indexed condition, and to 1 intervention - of which POEM Procedure is the first listed.
NCT02314741 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02314741 about?
NCT02314741 is a clinical study titled "Peroral Endoscopic Myotomy (POEM) for Esophageal Motility". The investigators wish to monitor the adoption of a new, incisionless approach to performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally providing similar if not be...
What is the current status of trial NCT02314741?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2014-05. Estimated completion is 2015-05.
What conditions does trial NCT02314741 study?
This clinical trial studies the following conditions: Achalasia.
What interventions are being tested in trial NCT02314741?
The interventions under investigation include: POEM Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT02314741?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02314741 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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