AchalasiaPOEMNCT01402518
Per-Oral Endoscopic Myotomy
An observational study of Achalasia, run by University of California, San Diego at 1 site in United States.
Trial summary
This is a prospective chart review/data collection study of the per oral endoscopic myotomy (POEM) procedure, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a POEM procedure. Data will be collected and reviewed through 12 months post-op. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Achalasia
- What is being tested?
- Per-oral enodscopic myotomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Nov 2019
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients between the ages of 18-75 who present in the UC San Diego Surgical Specialties clinic with the diagnosis of achalasia will be offered participation in this study.
Who may be able to join
- Diagnosis of achalasia
- Age 18-75
- Mentally competent to give informed consent
- Scheduled to undergo a POEM procedure
Who cannot join
- Pregnant women
- Any prior surgical treatment for achalasia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92103
About this study
Official title: Observational Study of the Per-Oral Endoscopic Myotomy (POEM) Procedure
This is a prospective chart review/data collection study of the per oral endoscopic myotomy (POEM) procedure, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a POEM procedure. Data will be collected and reviewed through 12 months post-op.
- Conditions
- Achalasia
- Being tested
- Per-oral enodscopic myotomy
- Keywords
- achalasia, myotomy, endoscopic myotomy, difficulty swallowing
- Medical subject headings
- Esophageal Achalasia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Per-oral enodscopic myotomyProcedure or surgery
Also called POEM
| Study group | Role | What they receive |
|---|---|---|
| Per-oral endoscopic myotomy | Not described Receives: Procedure: Per-oral enodscopic myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the outcomes of the per-oral endoscopic myotomy (POEM) procedure for the treatment of achalasia
Measured: 1 year
Secondary outcomes (1)
To assess the quality of life, pain, and complications of the POEM approach
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 posted26 Jul 2011 (estimated)
- Study startNov 2009
- Primary completionNov 2019
- Study completionNov 2019
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago Horgan, University of California, San Diego
- Investigators
- Santiago Horgan, M.D., FACS, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402518
- Sponsor's protocol ID
- 091170, 150261
- Acronym
- POEM
- Status last verified
- Apr 2018
- First submitted
- 21 Jul 2011
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Per-Oral Endoscopic Myotomy (POEM) Procedure
- ClinicalTrials.gov ID
- NCT01402518
- Acronym / sponsor ID
- POEM / 091170, 150261
- Conditions
- Achalasia
- Keywords
- achalasia, myotomy, endoscopic myotomy, difficulty swallowing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 26 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 prospective chart review/data collection study of the per oral endoscopic myotomy (POEM) procedure, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a POEM procedure. Data will be collected and reviewed through 12 months post-op.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Per-oral endoscopic myotomy | – | Procedure: Per-oral enodscopic myotomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-75 who present in the UC San Diego Surgical Specialties clinic with the diagnosis of achalasia will be offered participation in this study.
Key inclusion criteria (4 listed)
- Diagnosis of achalasia
- Age 18-75
- Mentally competent to give informed consent
- Scheduled to undergo a POEM procedure
Key exclusion criteria (2 listed)
- Pregnant women
- Any prior surgical treatment for achalasia
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 |
|---|---|---|
| Per-oral enodscopic myotomyAlso: POEM | Procedure or surgery | Per-oral endoscopic myotomy |
Primary outcome
To evaluate the outcomes of the per-oral endoscopic myotomy (POEM) procedure for the treatment of achalasia
Time frame: 1 year
1 secondary outcome
To assess the quality of life, pain, and complications of the POEM approach
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 10 Mar 2020.
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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.
Santiago Horgan, M.D., FACS principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achalasia, run by University of California, San Diego 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 2 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 10 Mar 2020. 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?
To evaluate the outcomes of the per-oral endoscopic myotomy (POEM) procedure for the treatment of achalasia (time frame: 1 year). 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 10 Mar 2020.