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POEM- Peroral Endoscopic Myotomy for Esophageal Motility Disorders (POEM)

This study is currently recruiting participants.
Verified April 2016 by Yoav Mintz, Hadassah Medical Organization
Sponsor:
ClinicalTrials.gov Identifier:
NCT01512719
First Posted: January 19, 2012
Last Update Posted: April 13, 2016
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.
Information provided by (Responsible Party):
Yoav Mintz, Hadassah Medical Organization
  Purpose
POEM has recently described as an alternative treatment for achalasia in humans. In this procedure the esophageal sphincter is incised through a submucosal tunnel in the esophagus. In this study we aim to perform POEM on achalasia patients.

Condition Intervention
Achalasia Procedure: POEM

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: POEM a Novel Endoscopic Treatment for Achalasia

Resource links provided by NLM:


Further study details as provided by Yoav Mintz, Hadassah Medical Organization:

Primary Outcome Measures:
  • Resolution of dysphagia [ Time Frame: up to 6 months postoperatively ]

Estimated Enrollment: 25
Study Start Date: January 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: POEM procedure
Patients with achalasia that undergo POEM
Procedure: POEM
Per Oral Endoscopic Myotomy for achalasia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Achalasia whom are candidates for Heller Myotomy

Exclusion Criteria:

  • Perforation of LES during dilatation
  • Pregnant women
  • mentally ill patients
  Contacts and Locations
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): NCT01512719


Contacts
Contact: Yoav Mintz, MD 97226776404 ymintz@hadasaah.org.il
Contact: Hadas Lemberg, PhD 0097226777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel, 12000
Principal Investigator: Yoav Mintz, Associate Professor of Surgery         
Hadassah Medical Center Recruiting
Jerusalem, Israel, 12000
Contact: Ronit Ungar    +972-26779694    ronitu@hadassah.org.il   
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Hadas Lemberg, PhD    0097226777572    lhadas@hadassah.org.il   
Sub-Investigator: Mahmoud Abu Gazala, MD         
Sub-Investigator: Harold Jacob, MD         
Sub-Investigator: Yael Kopelman, MD         
Hadassah Medical Organization Ein-Kerem campus Recruiting
Jerusalem, Israel
Contact: Yoav Mintz, MD         
Principal Investigator: Yoav Mintz, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Yoav Mintz, MD Hadassah Medical Organization
  More Information

Responsible Party: Yoav Mintz, Senior Lecturer, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01512719     History of Changes
Other Study ID Numbers: 040411-HMO-CTIL
First Submitted: January 15, 2012
First Posted: January 19, 2012
Last Update Posted: April 13, 2016
Last Verified: April 2016

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