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Enrolling By InvitationNCT02770859

Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
5,000 (estimated)
Sponsor
Indiana University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

POEM (Per-Oral endoscopic myotomy (creating a muscle \[esophagus\] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia.

Detailed description

Achalasia is a disease of the muscle of the esophagus (food tube) \& means "a failure to relax." The esophagus consists of 3 parts: the first part (uppermost part) is the upper esophageal sphincter (UES). The UES is a specialized ring of muscle which separates the esophagus from the throat, \& prevents food in the second part (body) of the esophagus from regurgitating into the throat. The third part of the esophagus (lower esophageal sphincter \[LES\]) also consists of a specialized ring of muscle which separates the body of the esophagus from the stomach, \& prevents food \& acid from regurgitating into the body of the esophagus. When achalasia is present, patients experience dysphasia (difficulty swallowing food, \& \[sometimes\] liquids), chest pain \& can experience recurrent pneumonia \& loss of weight. Current treatments for achalasia include oral medications (calcium channel blockers) to relax the LES (difficult to swallow pill/capsule), dilation (stretching) of the LES, (temporary relief) \& Esophagomyotomy (general surgery to cut the LES). POEM (Per-Oral endoscopic myotomy (creating a muscle \[esophagus\] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia.

Conditions

Interventions

TypeNameDescription
PROCEDUREPOEM (Per Oral Endoscopic Myotomy)Per-Oral endoscopic myotomy (creating a muscle \[esophagus\] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia

Timeline

Start date
2014-10-16
Primary completion
2040-01-31
Completion
2040-01-31
First posted
2016-05-12
Last updated
2026-02-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02770859. Inclusion in this directory is not an endorsement.