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Completed No phase listed Observational

Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

ClinicalTrials.gov ID: NCT01832779

Public ClinicalTrials.gov record NCT01832779. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 10:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy (POEM)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 routine medical care in US population. This will be a data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

Study identification

NCT ID
NCT01832779
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
University of Florida
Other
Enrollment
143 participants

Conditions and interventions

Conditions

Interventions

Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2013
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024
Last update posted
Oct 7, 2024

2013 – 2024

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Florida Health Gainesville Florida 32610

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01832779, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 7, 2024 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01832779 live on ClinicalTrials.gov.

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