Peroral Endoscopic Myotomy for the Treatment of Achalasia

Achalasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04640753
• Other study ID #: 031.GID.2018.D
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

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