ClinicalTrials.gg
RecruitingNCT04640753Updated Jun 10, 2026

Peroral Endoscopic Myotomy for the Treatment of Achalasia

An observational study in Achalasia, sponsored by Methodist Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Methodist Health System · Observational

From the registry’s dates

  • Started Feb 2019; still recruiting 7 years 9 months later.

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Study type
Observational
Model
Other
Time perspective
Other
Enrollment
200
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 52 studies in Esophageal Achalasia with a site in United States — 18 open to participants now, 18 under way, 2 of them phase 3. Esophageal Achalasia · United States.

Planned enrollment
7th of 19
200 · median 200
Started
2019
with 1 other
Observational
19 of 52
8 open now
Primary completion
2027-02
later than 4 of 17 live
Registered
34th of 52
by date

Among the 52 studies in Esophageal Achalasia with a site in United States, this one is the 7th largest by planned enrollment of the 19 observational ones that give a count, is one of 2 that started in 2019, is one of 19 observational ones, reaches primary completion later than 4 of the 17 other live ones, and was the 34th registered.

Esophageal Achalasia

143 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.

Browse Esophageal Achalasia studies →

Open to participants now

18 of the 52 studies in Esophageal Achalasia with a site in United States are open now. Recruiting first, the newest first:

12 more — sign in →

All 18 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 31 Esophageal Achalasia studies recruiting now, 20 (65%) set no upper age limit and 5 (16%) stop at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 52 studies in Esophageal Achalasia with a site in United States, or all of them as a file.
02

Study 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 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)."

03

Conditions studied

  • Achalasia

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Any patient who has not undergone POEM for the treatment of Achalasia.
  • Below 18 years of age
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • ProcedureEndoscopic procedure for achalasia

    POEM procedure will have a high technical feasibility, with effective clinical resolution of symptoms both in the short and long term.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: upto 180 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2019 (actual). Primary completion is estimated for Feb 2027, 95 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2019
First posted
Nov 23, 2020
StartActual
Feb 6, 2019
Primary completionEst.
Feb 5, 2027
CompletionEst.
Feb 5, 2027
Last update
Jun 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04640753
Responsible party
Sponsor
First posted
Nov 23, 2020
Start date
Feb 6, 2019
Primary completion
Feb 5, 2027 (estimated)
Completion
Feb 5, 2027 (estimated)
Last update
Jun 10, 2026

Study contacts

Crystee Cooper, DHEd
Contact
clinicalresearch@mhd.com
214-947-1280
Jennifer Kirchner
Contact
ClinicalResearch@mhd.com
214-947-4459
Prashant Kedia, M.D.
principal investigator · The Methodist Hospital Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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