Clinical trial NCT04640753: Peroral Endoscopic Myotomy for the Treatment of Achalasia
Official title: Peroral Endoscopic Myotomy for the Treatment of Achalasia: A Single-center Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Achalasia
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
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.

Brief 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

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)."

Eligibility criteria: 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

Primary outcomes:
measure: Decrease or no symptoms of chest pain
timeFrame: upto 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Prashant Kedia, M.D.
role: PRINCIPAL_INVESTIGATOR
References: