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Recruiting

NCT Number: NCT04640753

Peroral Endoscopic Myotomy for the Treatment of Achalasia

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location status: Recruiting

Location contact

Prashant Kedia, MD

CONTACT

About this study

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)."

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Endoscopic procedure for achalasia

Procedure

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Crystee Cooper, DHEd

CONTACT

[email protected]

214-947-1280

Jennifer Kirchner

CONTACT

[email protected]

214-947-4459

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Official study title

Peroral Endoscopic Myotomy for the Treatment of Achalasia: A Single-center Registry

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Nov 23, 2020
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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