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
|Condition or disease||Intervention/treatment|
|Achalasia||Procedure: POEM (Per Oral Endoscopic Myotomy)|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||150 participants|
|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|
- 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 achalasiaOther Name: POEM
- 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
- 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.
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
|United States, Indiana|
|Indiana University Hospital|
|Indianapolis, Indiana, United States, 46202-5121|
|Principal Investigator:||John M DeWitt, M.D.||Indiana University School of Medicine|