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NCT01832779 · ClinicalTrials.gov registry record
Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia
A clinical trial, sponsored by University of Florida.
- Completed
- Registry status
- 143
- Enrollment target
NCT01832779 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 143 participants.
The verdict
NCT01832779 has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 143 participants
- Enrollment target
Study Summary
Achalasia is a chronic disease of altered esophageal motility with resulting functional obstruction to the passage of food leading to poor quality of life and significant morbidity. The two main treatments available in the US are endoscopic balloon dilation and surgical myotomy. Each therapy has advantages and drawbacks and at present both are considered a first choice approach depending on patient preferences and local expertise. Surgical myotomy provides long lasting improvement in dysphagia but even when done laparoscopically is invasive and complex. Extensive acid reflux resulting in significant morbidity is routinely seen after surgical myotomy and additional anti-reflux operation is typically done at the time of the myotomy. Endoscopic balloon dilation is a simple minimally invasive outpatient procedure but improvement of symptoms tends to be shorter in duration and repeat dilations are commonly needed. Both therapies improve on dysphagia but tend to provide suboptimal control of chest pain which is one of the cardinal symptoms of achalasia. The peroral endoscopic myotomy (POEM) was first introduced in Japan to address the suboptimal results with endoscopic balloon dilation and surgical myotomy. POEM is incisionless minimally invasive but in addition may have some further advantages over surgical myotomy including unlimited length of the myotomy with expected better control of chest pain and preservation of the anatomical anti-reflux barrier (angle of His and the cruse of the diaphragm) with expected lower incidence of acid reflux. In Japan POEM has become the preferred modality for therapy of achalasia due to the excellent results and exceptional safety record. In the US, dedicated POEM devices were approved by the FDA just recently. As a result the bulk of the published data comes from Japan and very little is known regarding outcomes in US population. Therefore the investigators want to prospectively record our experience with POEM as done as part of rout
Interventions
- OTHER Achalasia subjects
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2013-03 |
| Est. Completion | 2024-05-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01832779
The ClinicalTrials.gov registry entry for NCT01832779 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Achalasia subjects is the first listed.
NCT01832779 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01832779 about?
NCT01832779 is a clinical study titled "Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia". Achalasia is a chronic disease of altered esophageal motility with resulting functional obstruction to the passage of food leading to poor quality of life and significant morbidity. The two main treatments available in the US are endoscopic balloon dilation and surgical myotomy. Each therapy has adv...
What is the current status of trial NCT01832779?
This trial is currently completed. The enrollment target is 143 participants. The study started on 2013-03. Estimated completion is 2024-05-01.
What interventions are being tested in trial NCT01832779?
The interventions under investigation include: Achalasia subjects (OTHER).
Who is sponsoring clinical trial NCT01832779?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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