Peroral Endoscopic Myotomy (POEM) For The Treatment Of Achalasia: A Registry (POEM Registry)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02162589|
Recruitment Status : Recruiting
First Posted : June 12, 2014
Last Update Posted : February 20, 2017
|Condition or disease||Intervention/treatment|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Peroral Endoscopic Myotomy (POEM) For The Treatment Of Achalasia: A Retrospective And Prospective Multicenter Registry.|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||December 1, 2017|
|Estimated Study Completion Date :||January 1, 2018|
POEM for Achalasia
Any patient who has undergone clinically indicated and/or standard of care POEM for the treatment of Achalasia.
Per oral endoscopic myotomy
- Clinical Success [ Time Frame: 1 year ]Documentation of clinical success rates such as achievement of symptoms remission (dysphagia, reflux, etc.) and reduced lower esophageal sphincter pressures (manometry).
- Safety Rate [ Time Frame: 6 months ]Documentation of Safety: Number of subjects with Adverse Events, Type, frequency and intensity of adverse events.
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): NCT02162589
|Contact: Michel Kahaleh, MDfirstname.lastname@example.org|
|Contact: Monica R Gaidhane, MPHemail@example.com|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10021|
|Contact: Michel Kahaleh, MD 646-962-4797 firstname.lastname@example.org|
|Contact: Monica R Gaidhane, MD, MPH 646-962-4796 email@example.com|
|Principal Investigator: Michel Kahaleh, MD|