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

July 28, 2020 updated by: Yoav Mintz, Hadassah Medical Organization

POEM a Novel Endoscopic Treatment for Achalasia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Medical Organization
        • Sub-Investigator:
          • Yael Kopelman, MD
        • Sub-Investigator:
          • Mahmoud Abu Gazala, MD
        • Sub-Investigator:
          • Harold Jacob, MD
      • Jerusalem, Israel, 12000
        • Recruiting
        • Hadassah Medical Center
        • Contact:
      • Jerusalem, Israel
        • Recruiting
        • Hadassah Medical Organization Ein-Kerem campus
        • Contact:
          • Yoav Mintz, MD
        • Principal Investigator:
          • Yoav Mintz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Achalasia whom are candidates for Heller Myotomy

Exclusion Criteria:

  • Perforation of LES during dilatation
  • Pregnant women
  • mentally ill patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: POEM procedure
Patients with achalasia that undergo POEM
Procedure: POEM
Per Oral Endoscopic Myotomy for achalasia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resolution of dysphagia
Time Frame: up to 6 months postoperatively
up to 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Yoav Mintz, MD, Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

January 15, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 040411-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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