Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 10:11 AM
Study NCT ID:
NCT02770859
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-25
First Post:
2016-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POEM
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: