AchalasiaPOEMNCT01399476
Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia
A study testing Endoscopic Myotomy and Endoscopic Myotomy for treatment of achalasia in people with Achalasia, run by The Oregon Clinic at 1 site in United States.
Trial summary
This is a study of the safety and efficacy of a new surgical procedure using endoscopic instruments and a tunneling technique to reach the LES for dissection. We hypothesize that this technique provides an incisionless, less invasive option with similar functional outcome compared to standard Heller myotomy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Achalasia
- What is being tested?
- Endoscopic Myotomy and Endoscopic Myotomy for treatment of achalasia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to undergo general anesthesia
- Age > 18 yrs. of age and < 85 yrs. of age
- Ability to give informed consent
- Candidate for elective Heller myotomy
Who cannot join
- Previous mediastinal or esophageal surgery
- Contraindications for esophagogastroduodenoscopy
- BMI > 45
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia
This is a study of the safety and efficacy of a new surgical procedure using endoscopic instruments and a tunneling technique to reach the LES for dissection. We hypothesize that this technique provides an incisionless, less invasive option with similar functional outcome compared to standard Heller myotomy.
Read the detailed description
By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer can be easily visualized. In contrast to conventional Heller myotomy, the dissection of only the inner circular esophageal muscle layer leaves the outer longitudinal muscle layer intact. Thereby, post-interventional reflux disease should be avoided.
- Conditions
- Achalasia
- Being tested
- Endoscopic Myotomy, Endoscopic Myotomy for treatment of achalasia
- Keywords
- 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.
Endoscopic MyotomyProcedure or surgery
Also called POEM
Patients will receive the surgical procedure described in the summary (POEM).
Endoscopic Myotomy for treatment of achalasiaProcedure or surgery
Also called POEM
Surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Myotomy | Experimental | Not described Receives: Procedure: Endoscopic Myotomy; Procedure: Endoscopic Myotomy for treatment of achalasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved quality of life as defined by survey pre and post surgery
patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.
Measured: six months
Secondary outcomes (2)
Negative pH test
Patients will be required to have 24 hour pH testing after surgery.
Measured: six months
Bleeding
recorded blood loss will be taken during surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Oregon Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Swanstrom, The Oregon Clinic
- Investigators
- Lee L Swanstrom, MD, Principal investigator, The Oregon Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399476
- Sponsor's protocol ID
- 1056
- Acronym
- POEM
- Status last verified
- Aug 2019
- First submitted
- 19 Jul 2011
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kurian AA, Dunst CM, Sharata A, Bhayani NH, Reavis KM, Swanstrom LL. Peroral endoscopic esophageal myotomy: defining the learning curve. Gastrointest Endosc. 2013 May;77(5):719-25. doi: 10.1016/j.gie.2012.12.006. Epub 2013 Feb 5.
PubMed 23394838
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia
- ClinicalTrials.gov ID
- NCT01399476
- Acronym / sponsor ID
- POEM / 1056
- Conditions
- Achalasia
- Keywords
- Achalasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- The Oregon ClinicUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 21 Jul 2011 (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 study of the safety and efficacy of a new surgical procedure using endoscopic instruments and a tunneling technique to reach the LES for dissection. We hypothesize that this technique provides an incisionless, less invasive option with similar functional outcome compared to standard Heller myotomy.
Detailed description
By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer can be easily visualized. In contrast to conventional Heller myotomy, the dissection of only the inner circular esophageal muscle layer leaves the outer longitudinal muscle layer intact. Thereby, post-interventional reflux disease should be avoided.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Myotomy | Experimental | Procedure: Endoscopic Myotomy, Procedure: Endoscopic Myotomy for treatment of achalasia |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to undergo general anesthesia
- Age > 18 yrs. of age and < 85 yrs. of age
- Ability to give informed consent
- Candidate for elective Heller myotomy
Key exclusion criteria (3 listed)
- Previous mediastinal or esophageal surgery
- Contraindications for esophagogastroduodenoscopy
- BMI > 45
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 |
|---|---|---|
| Endoscopic MyotomyAlso: POEMPatients will receive the surgical procedure described in the summary (POEM). | Procedure or surgery | Endoscopic Myotomy |
| Endoscopic Myotomy for treatment of achalasiaAlso: POEMSurgical procedure | Procedure or surgery | Endoscopic Myotomy |
Primary outcome
Improved quality of life as defined by survey pre and post surgery
Time frame: six months
patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.
2 secondary outcomes
Negative pH test
Time frame: six months
Bleeding
Time frame: 1 year
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 30 Aug 2019.
- Derived from this study: PubMed 23394838Kurian AA, Dunst CM, Sharata A, Bhayani NH, Reavis KM, Swanstrom LL. Peroral endoscopic esophageal myotomy: defining the learning curve. Gastrointest Endosc. 2013 May;77(5):719-25. doi: 10.1016/j.gie.2012.12.006. Epub 2013 Feb 5.
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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.
Lee L Swanstrom, MD principal investigator
The Oregon 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 Endoscopic Myotomy and Endoscopic Myotomy for treatment of achalasia in people with Achalasia, run by The Oregon 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 4 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 30 Aug 2019. 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?
Improved quality of life as defined by survey pre and post surgery (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01399476, which also lists 1 linked publication.
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 30 Aug 2019.