POEM- Peroral Endoscopic Myotomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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: April 3, 2014
Last verified: April 2014
  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:


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 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (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
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, see Learn About Clinical Studies.

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 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         
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   
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: April 3, 2014
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 October 19, 2014