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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: Completed study, sponsored by University of Florida.

NCT01832779 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 143 participants. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Information about the subject's medical history, leading up to the need for an Achalasia treatment, the procedure itself and how the subject does after the procedure, including after the subject gets home, will be collected. This information will be collected by gathering relevant information from the subject's medical chart and/or by talking with the subject prior to and after the subject's medical procedures. There are no specific study procedures or tests. All information collected is part

Interventions

  • OTHER Achalasia subjects

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2013-03
Est. Completion 2024-05-01
University of Florida

1,106 total trials

What the finished NCT01832779 record still lists

NCT01832779 is an observational study that tracks outcomes without assigning an intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which Achalasia subjects is the first listed.

NCT01832779 does not publish any study locations in the registry export this page uses.

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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Source: ClinicalTrials.gov NCT01832779, the US trial registry maintained by the National Library of Medicine. NCT01832779 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.