AchalasiaPOEMNCT01584635
The Role That Peroral Endoscopic Myotomy (POEM) Could Play in the Treatment of Achalasia
A study testing Peroral Endoscopic Myotomy a less invasive treatment for Achalasia in people with Achalasia, run by Mayo Clinic at 1 site in United States.
Trial summary
Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less invasive treatment for Achalasia has been developed. The purpose of this study is to decide the role this less invasive treatment (Peroral Endoscopic Myotomy) has in the treatment of patient's with achalasia. 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 a less invasive treatment for Achalasia
- 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
- Jan 2012to Jan 2016
- 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 between the ages of 18 and 80 with achalasia diagnosed by a combination of compatible symptoms, barium esophagography and high resolution manometry.
Who cannot join
- Patients who are poor surgical risks, have had previous treatment for achalasia or esophageal or gastric surgery, have an epiphrenic diverticulum or are unwilling to be followed in the protocol.
- Female patients are eligible if they are NOT pregnant or lactating AND ne of the following criteria is met:
- The patient is surgically sterile (by means of hysterectomy/bilateral tubal ligation)
- The patient is at least one year postmenopausal (no menses for 12 months).
- The patient is using a highly effective method of contraception, if childbearing potential, AND has a negative urine human chorionic gonadotropin beta subunit (ß HCG) pregnancy test result during Screening, and prior to trial drug administration.
- Highly effective methods of birth control are defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
- Withdrawal, single- or double barrier methods (including condoms) and rhythm methods are NOT ACCEPTABLE methods of contraception for the purposes of this clinical trial due to the high incidence of contraceptive failures with these methods.
- Vulnerable populations, such as those with diminished mental acuity, will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peroral Endoscopic Myotomy (POEM) for Treatment of Achalasia
Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less invasive treatment for Achalasia has been developed.
The purpose of this study is to decide the role this less invasive treatment (Peroral Endoscopic Myotomy) has in the treatment of patient's with achalasia.
- Conditions
- Achalasia
- Being tested
- Peroral Endoscopic Myotomy a less invasive treatment for Achalasia
- Keywords
- Less invasive treatment for Achalasia
- 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 a less invasive treatment for AchalasiaProcedure or surgery
Also called Achalasia, Heller myotomy, Dysphagia, Peroral Endoscopic Myotomy
In this study we will follow patients undergoing Peroral Endoscopic Myotomy at 1 and 6 months post surgery,1,2,3,4,and 5 years post surgery with esophageal high resolution Manometry and a Barium Esophagram when it is not standard of care. We will have you fill out a symptom questionnaire at each visit
| Study group | Role | What they receive |
|---|---|---|
| Peroral Endoscopic Myotomy (POEM) | Experimental | Peroral Endoscopic Myotomy- a less invasive treatment for patients with Achalasia Receives: Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Patients in this study, undergoing the Peroral Endoscopic Myotomy treatment for Achalasia, will be accessed at 1 month, 6 months, at 1-2-3-4 and year 5 post surgery. We will measure outcomes by number of adverse events, Eckardt symptom score, barium esophagram, and manometry studies.
Measured: 5 years post surgery
Secondary outcomes (1)
Eckardt symptom score
By following participants regularly and closely both by symptomatic and objective criteria, we will be able to determine factors that predict response to the POEMS procedure.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2016
- Study completionJan 2016
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 Mayo ClinicThe 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
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Katzka, Mayo Clinic
- Investigators
- David Katzka, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584635
- Sponsor's protocol ID
- 11-005252
- Acronym
- POEM
- Status last verified
- Oct 2016
- First submitted
- 12 Jan 2012
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peroral Endoscopic Myotomy (POEM) for Treatment of Achalasia
- ClinicalTrials.gov ID
- NCT01584635
- Acronym / sponsor ID
- POEM / 11-005252
- Conditions
- Achalasia
- Keywords
- Less invasive treatment for Achalasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Apr 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.
Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less invasive treatment for Achalasia has been developed.
The purpose of this study is to decide the role this less invasive treatment (Peroral Endoscopic Myotomy) has in the treatment of patient's with achalasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peroral Endoscopic Myotomy (POEM) | Experimental | Procedure: Peroral Endoscopic Myotomy a less invasive treatment for AchalasiaPeroral Endoscopic Myotomy- a less invasive treatment for patients with Achalasia |
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 between the ages of 18 and 80 with achalasia diagnosed by a combination of compatible symptoms, barium esophagography and high resolution manometry.
Key exclusion criteria (8 listed)
- Patients who are poor surgical risks, have had previous treatment for achalasia or esophageal or gastric surgery, have an epiphrenic diverticulum or are unwilling to be followed in the protocol.
- Female patients are eligible if they are NOT pregnant or lactating AND ne of the following criteria is met:
- The patient is surgically sterile (by means of hysterectomy/bilateral tubal ligation)
- The patient is at least one year postmenopausal (no menses for 12 months).
- The patient is using a highly effective method of contraception, if childbearing potential, AND has a negative urine human chorionic gonadotropin beta subunit (ß HCG) pregnancy test result during Screening, and prior to trial drug administration.
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 a less invasive treatment for AchalasiaAlso: Achalasia, Heller myotomy, Dysphagia, Peroral Endoscopic MyotomyIn this study we will follow patients undergoing Peroral Endoscopic Myotomy at 1 and 6 months post surgery,1,2,3,4,and 5 years post surgery with esophageal high resolution Manometry and a Barium Esophagram when it is not standard of care. We will have you fill out a symptom questionnaire at each visit | Procedure or surgery | Peroral Endoscopic Myotomy (POEM) |
Primary outcome
Number of participants with adverse events
Time frame: 5 years post surgery
Patients in this study, undergoing the Peroral Endoscopic Myotomy treatment for Achalasia, will be accessed at 1 month, 6 months, at 1-2-3-4 and year 5 post surgery. We will measure outcomes by number of adverse events, Eckardt symptom score, barium esophagram, and manometry studies.
1 secondary outcome
Eckardt symptom score
Time frame: 5 years
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 31 Oct 2016.
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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.
David Katzka, MD principal investigator
Mayo Clinic
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 a less invasive treatment for Achalasia in people with Achalasia, run by Mayo Clinic 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 1 inclusion and 8 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 31 Oct 2016. 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?
Number of participants with adverse events (time frame: 5 years post surgery). 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 31 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.