AchalasiaPOEMNCT02073578
Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia
A study testing Peroral Endoscopic Myotomy (POEM) in people with Achalasia, run by Ohio State University at 1 site in United States.
Trial summary
This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat 20 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?
- Peroral Endoscopic Myotomy (POEM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2014
- 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
- Diagnosis of Achalasia
- Age 16-80
- ASA Class 1-3
Who cannot join
- Pregnancy
- Any prior surgical or endoscopic treatment for achalasia -- first eight subjects.
- After eight subjects have been treated as part of this study, this exclusion criteria no longer applies
- Patients who are taking immunosuppressive medications or are immunocompromised
- Patients on anticoagulant medications or abnormal coagulation tests
- Patients with severe medical comorbidities, in the judgment of the treating surgeon
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat 20 patients.
Read the detailed description
This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat or attempt to treat 20 patients. Patients for whom a POEM has been attempted but not completed (conversion to open or laparoscopic surgery, POEM surgery aborted and not re-attempted). Patients who proceed to study treatment will undergo ten years of follow-up as part of this study.
- Conditions
- Achalasia
- Being tested
- Peroral Endoscopic Myotomy (POEM)
- Keywords
- achalasia, POEM, peroral endoscopic myotomy, myotomy, Heller myotomy
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peroral Endoscopic Myotomy (POEM)Procedure or surgery
Endoscopy myotomy for treatment of achalasia
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Peroral Endoscopic Myotomy (POEM) Receives: Procedure: Peroral Endoscopic Myotomy (POEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Efficacy of POEM Procedure
To assess adverse events related to POEM
Measured: Intraoperative to one year follow-up
Long-term patient-reported quality of life
To assess change in quality of life from baseline, based on validated quality of life measures, at baseline through 1 year follow-up.
Measured: Baseline to one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startAug 2012
- Primary completionSep 2014
- Study completionDec 2014
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 Ohio State UniversityThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle A Perry, Ohio State University
- Investigators
- Kyle M Perry, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073578
- Sponsor's protocol ID
- 2011H0240
- Acronym
- POEM
- Status last verified
- Sep 2021
- First submitted
- 24 Feb 2014
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia
- ClinicalTrials.gov ID
- NCT02073578
- Acronym / sponsor ID
- POEM / 2011H0240
- Conditions
- Achalasia
- Keywords
- achalasia, POEM, peroral endoscopic myotomy, myotomy, Heller myotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Feb 2014 (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.
This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat 20 patients.
Detailed description
This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat or attempt to treat 20 patients. Patients for whom a POEM has been attempted but not completed (conversion to open or laparoscopic surgery, POEM surgery aborted and not re-attempted). Patients who proceed to study treatment will undergo ten years of follow-up as part of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Procedure: Peroral Endoscopic Myotomy (POEM)Peroral Endoscopic Myotomy (POEM) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Achalasia
- Age 16-80
- ASA Class 1-3
Key exclusion criteria (6 listed)
- Pregnancy
- Any prior surgical or endoscopic treatment for achalasia -- first eight subjects.
- After eight subjects have been treated as part of this study, this exclusion criteria no longer applies
- Patients who are taking immunosuppressive medications or are immunocompromised
- Patients on anticoagulant medications or abnormal coagulation tests
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 |
|---|---|---|
| Peroral Endoscopic Myotomy (POEM)Endoscopy myotomy for treatment of achalasia | Procedure or surgery | Treatment |
Primary outcome
Safety and Efficacy of POEM Procedure
Time frame: Intraoperative to one year follow-up
To assess adverse events related to POEM
Long-term patient-reported quality of life
Time frame: Baseline to one year follow-up
To assess change in quality of life from baseline, based on validated quality of life measures, at baseline through 1 year follow-up.
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 27 Sep 2021.
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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.
Kyle M Perry, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peroral Endoscopic Myotomy (POEM) in people with Achalasia, run by Ohio State University at 1 site in United States.
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 3 inclusion and 6 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 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Safety and Efficacy of POEM Procedure (time frame: Intraoperative to one year follow-up). The study lists 2 primary outcomes in all. 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 27 Sep 2021.