NCT01512719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

October 2, 2025

Status Verified

March 1, 2025

Enrollment Period

10 years

First QC Date

January 15, 2012

Last Update Submit

September 29, 2025

Conditions

Achalasia

Outcome Measures

Primary Outcomes (1)

  • Resolution of dysphagia

    up to 6 months postoperatively

Study Arms (1)

POEM procedure

EXPERIMENTAL

Patients with achalasia that undergo POEM

Procedure: POEM

Interventions

POEMPROCEDURE

Per Oral Endoscopic Myotomy for achalasia

POEM procedure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Achalasia whom are candidates for Heller Myotomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hadassah Medical Center

Jerusalem, 12000, Israel

Location

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Hadassah Medical Organization Ein-Kerem campus

Jerusalem, Israel

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Yoav Mintz, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2012

First Posted

January 19, 2012

Study Start

January 1, 2013

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

October 2, 2025

Record last verified: 2025-03

Locations

IL(3)