AchalasiaPOEMNCT01512719
POEM- Peroral Endoscopic Myotomy for Esophageal Motility Disorders
A study testing POEM in people with Achalasia, run by Hadassah Medical Organization at 3 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Achalasia
- What is being tested?
- POEM
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesIsrael
- Study dates
- Jan 2013to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Achalasia whom are candidates for Heller Myotomy
Who cannot join
- Perforation of LES during dilatation
- Pregnant women
- mentally ill patients
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Hadassah Medical Center
Jerusalem, 12000
Hadassah Medical Organization
Jerusalem, 91120
Hadassah Medical Organization Ein-Kerem campus
Jerusalem
About this study
Official title: 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.
- Conditions
- Achalasia
- Being tested
- POEM
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POEMProcedure or surgery
Per Oral Endoscopic Myotomy for achalasia
| Study group | Role | What they receive |
|---|---|---|
| POEM procedure | Experimental | Patients with achalasia that undergo POEM Receives: Procedure: POEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of dysphagia
Measured: up to 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2023
- Study completionJan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoav Mintz, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512719
- Sponsor's protocol ID
- 040411-HMO-CTIL
- Acronym
- POEM
- Status last verified
- Mar 2025
- First submitted
- 15 Jan 2012
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POEM a Novel Endoscopic Treatment for Achalasia
- ClinicalTrials.gov ID
- NCT01512719
- Acronym / sponsor ID
- POEM / 040411-HMO-CTIL
- Conditions
- Achalasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2023 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POEM procedure | Experimental | Procedure: POEMPatients with achalasia that undergo POEM |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Achalasia whom are candidates for Heller Myotomy
Key exclusion criteria (3 listed)
- Perforation of LES during dilatation
- Pregnant women
- mentally ill patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POEMPer Oral Endoscopic Myotomy for achalasia | Procedure or surgery | POEM procedure |
Primary outcome
Resolution of dysphagia
Time frame: up to 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
Related trials for Achalasia
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Full-thickness Versus Progressive Myotomy in Peroral Endoscopic Esophageal Myotomy in Achalasia: A Randomized Controlled Trial
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PREcision MEDicine In Achalasia (PREMEDIA)
Type I Achalasia, Type II Achalasia
RecruitingObservational study
PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features
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VZV in the Enteric Nervous System: Pathogenesis and Consequences
Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoav Mintz, MD principal investigator
Hadassah Medical Organization
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POEM in people with Achalasia, run by Hadassah Medical Organization at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of dysphagia (time frame: up to 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.