Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02770859
Recruitment Status : Enrolling by invitation
First Posted : May 12, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
John DeWitt, Indiana University

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
Achalasia 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository
Actual Study Start Date : October 2014
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2050

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy


Intervention Details:
  • 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
    Other Name: POEM


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." [ Time Frame: 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. [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients over the age of 18 with demonstrated symptoms of Type II or Type III achalasia.
Criteria

Inclusion Criteria:

18 years of age Referral for the treatment of Achalasia

Exclusion Criteria:

Less than 18 years of age; Absence of Achalasia


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770859


Locations
Layout table for location information
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202-5121
Sponsors and Collaborators
Indiana University
Investigators
Layout table for investigator information
Principal Investigator: John M DeWitt, M.D. Indiana University School of Medicine

Additional Information:

Layout table for additonal information
Responsible Party: John DeWitt, Director, Endoscopic Ultrasound, Indiana University
ClinicalTrials.gov Identifier: NCT02770859    
Other Study ID Numbers: 1410540149
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by John DeWitt, Indiana University:
Achalasia
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases