CClinicalTrials.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

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

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)."

02

Conditions studied

  • Achalasia

Browse trials for

03

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.

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
04

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.

05

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

06

Study locations

1 of 1 sites recruiting
  • Methodist Dallas Medical Center
    Dallas, Texas 75203, United States
    • Prashant Kedia, MD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04640753
Lead sponsor
Methodist Health System
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 ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion