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POEM- Peroral Endoscopic Myotomy

This study is not yet open for participant recruitment.
Verified January 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Yoav Mintz, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01512719
First received: January 15, 2012
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: POEM a Novel Endoscopic Treatment for Achalasia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Resolution of dysphagia [ Time Frame: up to 6 months postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512719

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

Locations
Israel
Hadassah Medical Organization Not yet 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
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Yoav Mintz, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Yoav Mintz, Senior Lecturer, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01512719     History of Changes
Other Study ID Numbers: 040411-HMO-CTIL
Study First Received: January 15, 2012
Last Updated: January 18, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on May 16, 2013