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

Sponsor
Indiana University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02770859
Collaborator
(none)
500
1
423
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: POEM (Per Oral Endoscopic Myotomy)

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
500 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository
Actual Study Start Date :
Oct 1, 2014
Anticipated Primary Completion Date :
Jan 1, 2040
Anticipated Study Completion Date :
Jan 1, 2050

Outcome Measures

Primary Outcome Measures

  1. This is a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound for patients with achalasia. Achalasia is a disease of the muscle of the esophagus (food tube) & means "a failure to relax." [5 years]

    Data will be collected for research purposes only, to determine the clinical impact of endoscopic ultrasound treatment of achalasia

Secondary Outcome Measures

  1. Improved achalasia management. [5 years]

    The purpose of tracking this data will also help the physicians to better understand the patient's condition and disease process, which may lead to improved standard of care and improved patient management.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

18 years of age Referral for the treatment of Achalasia

Exclusion Criteria:

Less than 18 years of age; Absence of Achalasia

Contacts and Locations

Locations

Site City State Country Postal Code
1 Indiana University Hospital Indianapolis Indiana United States 46202-5121

Sponsors and Collaborators

  • Indiana University

Investigators

  • Principal Investigator: John M DeWitt, M.D., Indiana University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
John DeWitt, Director, Endoscopic Ultrasound, Indiana University
ClinicalTrials.gov Identifier:
NCT02770859
Other Study ID Numbers:
  • 1410540149
First Posted:
May 12, 2016
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by John DeWitt, Director, Endoscopic Ultrasound, Indiana University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022