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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02770859
Other study ID # 1410540149
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 16, 2014
Est. completion date January 31, 2040

Study information

Verified date January 2024
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 5000
Est. completion date January 31, 2040
Est. primary completion date January 31, 2040
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 18 years of age Referral for the treatment of Achalasia Exclusion Criteria: Less than 18 years of age; Absence of Achalasia

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
POEM (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

Locations

Country Name City State
United States Indiana University Hospital Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improved Eckardt Score Consists of 4 questions used to characterize the severity of achalasia. The questions include symptoms related to dysphagia, chest pain, regurgitation, and weight loss. Each question is assigned a score from 0 to 3 based on the patient's self reported response.
The overall score ranges from 0-12, with anything less than 3 meaning no active symptoms, and anything higher than a 3 suggestive of active symptoms.
5 years
See also
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