AchalasiaNCT04640753
Peroral Endoscopic Myotomy for the Treatment of Achalasia
An observational study of Achalasia, run by Methodist Health System at 1 site in United States.
Trial summary
There will be a retrospective chart review for patients who underwent endoscopic procedures and POEM from 06/2016 - 01/2019 \& a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia
- What is being tested?
- Endoscopic procedure for achalasia
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2019to 5 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: There will be a retrospective chart review for patients who underwent endoscopic procedures and POEM from 06/2016 - 01/2019. In addition; a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021.
Who may be able to join
- Any discharged patient who has undergone clinically indicated and/or standard of care POEM for the treatment of Achalasia from 6/2016 to 6/2021.
- Above or equal to 18 years of age
Who cannot join
- Any patient who has not undergone POEM for the treatment of Achalasia.
- Below 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center
Dallas, Texas, 75203
Prashant Kedia, MD
About this study
Official title: Peroral Endoscopic Myotomy for the Treatment of Achalasia: A Single-center Registry
There will be a retrospective chart review for patients who underwent endoscopic procedures and POEM from 06/2016 - 01/2019 \& a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021
Read the detailed description
Subjects will undergo no additional tests and procedures as part of this study. All data will be collected from patient's electronic health records (EHR) of the hospital In addition; a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021. All the subjects enrolled in prospective chart review will be first consented for their study participation. Subjects will undergo a clinically indicated endoscopic procedure and POEM and subsequent follow-up clinical visits as part of their standard medical care. All procedures, barring research activities such as consenting and data collection from Electronic Health Records, will be either clinically indicated and/or standard of care.
- Each patient in the study will be assigned a Case ID number to de-identify their personal health information during data collection
- The Case ID number connecting the patient to the personal health information will be in an encrypted electronic file on a computer that can only be accessed by study members at MDMC.
- A procedure report and outpatient clinical records for each subject's POEM procedure will be used to record each patient's data for the registry
- That data will only be shared by members of the study (PIs, research coordinator) who require it for conducting of data collection/interpretation
"Disclaimer: Any cost associated with the procedures stated herein will be billed directly to you or to your insurance (as applicable)."
- Conditions
- Achalasia
- Being tested
- Endoscopic procedure 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.
Endoscopic procedure for achalasiaProcedure or surgery
POEM procedure will have a high technical feasibility, with effective clinical resolution of symptoms both in the short and long term.
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease or no symptoms of chest pain
To continue and review our treatment outcomes, patient safety in cases with achalasia, we follow up after the procedure up to 180 days. Follow-up period varies from patient to patient.
Measured: upto 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start6 Feb 2019
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
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
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prashant Kedia, M.D., Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640753
- Sponsor's protocol ID
- 031.GID.2018.D
- Status last verified
- Jun 2026
- First submitted
- 27 Nov 2019
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peroral Endoscopic Myotomy for the Treatment of Achalasia: A Single-center Registry
- ClinicalTrials.gov ID
- NCT04640753
- Acronym / sponsor ID
- 031.GID.2018.D
- Conditions
- Achalasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 23 Nov 2020 (actual)
- 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.
There will be a retrospective chart review for patients who underwent endoscopic procedures and POEM from 06/2016 - 01/2019 \& a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021
Detailed description
Subjects will undergo no additional tests and procedures as part of this study. All data will be collected from patient's electronic health records (EHR) of the hospital In addition; a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021. All the subjects enrolled in prospective chart review will be first consented for their study participation. Subjects will undergo a clinically indicated endoscopic procedure and POEM and subsequent follow-up clinical visits as part of their standard medical care. All procedures, barring research activities such as consenting and data collection from Electronic Health Records, will be either clinically indicated and/or standard of care.
- Each patient in the study will be assigned a Case ID number to de-identify their personal health information during data collection
- The Case ID number connecting the patient to the personal health information will be in an encrypted electronic file on a computer that can only be accessed by study members at MDMC.
- A procedure report and outpatient clinical records for each subject's POEM procedure will be used to record each patient's data for the registry
- That data will only be shared by members of the study (PIs, research coordinator) who require it for conducting of data collection/interpretation
"Disclaimer: Any cost associated with the procedures stated herein will be billed directly to you or to your insurance (as applicable)."
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- There will be a retrospective chart review for patients who underwent endoscopic procedures and POEM from 06/2016 - 01/2019. In addition; a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021.
Key inclusion criteria (2 listed)
- Any discharged patient who has undergone clinically indicated and/or standard of care POEM for the treatment of Achalasia from 6/2016 to 6/2021.
- Above or equal to 18 years of age
Key exclusion criteria (2 listed)
- Any patient who has not undergone POEM for the treatment of Achalasia.
- Below 18 years of age
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 procedure for achalasiaPOEM procedure will have a high technical feasibility, with effective clinical resolution of symptoms both in the short and long term. | Procedure or surgery | – |
Primary outcome
Decrease or no symptoms of chest pain
Time frame: upto 180 days
To continue and review our treatment outcomes, patient safety in cases with achalasia, we follow up after the procedure up to 180 days. Follow-up period varies from patient to patient.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Prashant Kedia, M.D. principal investigator
The Methodist Hospital Research Institute
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 Methodist Health System 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 2 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystee Cooper, DHEd (214-947-1280, clinicalresearch@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease or no symptoms of chest pain (time frame: upto 180 days). 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 Jun 2026.