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POEM- Peroral Endoscopic Myotomy for Esophageal Motility Disorders (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. 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: NCT01512719
Recruitment Status : Recruiting
First Posted : January 19, 2012
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Yoav Mintz, Hadassah Medical Organization

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Achalasia Procedure: POEM Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: POEM a Novel Endoscopic Treatment for Achalasia
Study Start Date : January 2013
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: POEM procedure
Patients with achalasia that undergo POEM
 Procedure: POEM
Per Oral Endoscopic Myotomy for achalasia


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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
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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
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Contact: Yoav Mintz, MD 97226776404 ymintz@hadasaah.org.il
Contact: Hadas Lemberg, PhD 0097226777572 lhadas@hadassah.org.il

Locations
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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
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Principal Investigator: Yoav Mintz, MD Hadassah Medical Organization
More Information
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Responsible Party: Yoav Mintz, Senior Lecturer, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01512719    
Other Study ID Numbers: 040411-HMO-CTIL
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases