Back to results

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

Primary Purpose

Achalasia

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

POEM

About this trial

This is an interventional treatment trial for Achalasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with Achalasia whom are candidates for Heller Myotomy

Exclusion Criteria:

Perforation of LES during dilatation
Pregnant women
mentally ill patients

Sites / Locations

Hadassah Medical CenterRecruiting
Hadassah Medical CenterRecruiting
Hadassah Medical OrganizationRecruiting
Hadassah Medical Organization Ein-Kerem campusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

POEM procedure

Arm Description

Patients with achalasia that undergo POEM

Outcomes

Primary Outcome Measures

Resolution of dysphagia

Secondary Outcome Measures

Full Information

NCT ID

NCT01512719

First Posted

January 15, 2012

Last Updated

July 28, 2020

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT01512719

Brief Title

POEM- Peroral Endoscopic Myotomy for Esophageal Motility Disorders

Acronym

POEM

Official Title

POEM a Novel Endoscopic Treatment for Achalasia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

January 2021 (Anticipated)

Study Completion Date

January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Achalasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

POEM procedure

Arm Type

Experimental

Arm Description

Patients with achalasia that undergo POEM

Intervention Type

Procedure

Intervention Name(s)

POEM

Intervention Description

Per Oral Endoscopic Myotomy for achalasia

Primary Outcome Measure Information:

Title

Resolution of dysphagia

Time Frame

up to 6 months postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with Achalasia whom are candidates for Heller Myotomy Exclusion Criteria: Perforation of LES during dilatation Pregnant women mentally ill patients

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yoav Mintz, MD

Phone

97226776404

ymintz@hadasaah.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Hadas Lemberg, PhD

Phone

0097226777572

lhadas@hadassah.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoav Mintz, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Center

City

Jerusalem

ZIP/Postal Code

12000

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yoav Mintz, Associate Professor of Surgery

Facility Name

Hadassah Medical Center

City

Jerusalem

ZIP/Postal Code

12000

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ronit Ungar

Phone

+972-26779694

ronitu@hadassah.org.il

Facility Name

Hadassah Medical Organization

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hadas Lemberg, PhD

Phone

0097226777572

lhadas@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Mahmoud Abu Gazala, MD

First Name & Middle Initial & Last Name & Degree

Harold Jacob, MD

First Name & Middle Initial & Last Name & Degree

Yael Kopelman, MD

Facility Name

Hadassah Medical Organization Ein-Kerem campus

City

Jerusalem

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yoav Mintz, MD

First Name & Middle Initial & Last Name & Degree

Yoav Mintz, MD

12. IPD Sharing Statement

Learn more about this trial

POEM- Peroral Endoscopic Myotomy for Esophageal Motility Disorders

We'll reach out to this number within 24 hrs