ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University

Brief Summary:
Prospective Multicenter registry study to assess the safety and efficacy of clinically indicated peroral endoscopic myotomy (POEM) for the treatment of Achalasia

Condition or disease Intervention/treatment
Achalasia Procedure: POEM

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
POEM for Achalasia
Any patient who has undergone clinically indicated and/or standard of care POEM for the treatment of Achalasia.
Procedure: POEM
Per oral endoscopic myotomy




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Safety Rate [ Time Frame: 6 months ]
    Documentation of Safety: Number of subjects with Adverse Events, Type, frequency and intensity of adverse events.



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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient who has undergone clinically indicated and/or standard of care POEM for the treatment of Achalasia and above or equal to 18 years of age
Criteria

Inclusion Criteria:

  1. Any patient who has undergone clinically indicated and/or standard of care POEM for the treatment of Achalasia
  2. Above or equal to 18 years of age

Exclusion Criteria:

  1. Any patient who has not undergone POEM for the treatment of Achalasia
  2. Below 18 years of age

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): NCT02162589


Contacts
Contact: Michel Kahaleh, MD 646-962-4797 mik9071@med.cornell.edu
Contact: Monica R Gaidhane, MPH 646-962-4796 mog2012@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Michel Kahaleh, MD    646-962-4797    mkahaleh@gmail.com   
Contact: Monica R Gaidhane, MD, MPH    646-962-4796    mog2012@med.cornell.edu   
Principal Investigator: Michel Kahaleh, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michel Kahaleh, Chief of Endoscopy, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02162589     History of Changes
Other Study ID Numbers: 1309014292
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD sharing

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases