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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04640753
Other study ID # 031.GID.2018.D
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 6, 2019
Est. completion date February 5, 2024

Study information

Verified date July 2023
Source Methodist Health System
Contact Crystee Cooper, DHEd
Phone 214-947-1280
Email clinicalresearch@mhd.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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)."


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date February 5, 2024
Est. primary completion date February 5, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. upto 180 days
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