Evaluation of Peroral Endoscopic Myotomy to Treat Zenker's Diverticulum

Last updated: March 26, 2024
Sponsor: Methodist Health System
Overall Status: Active - Enrolling

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Treatment

ZPOEM

Clinical Study ID

NCT05157984
031.GID.2021.D
2020.11.16
  • Ages > 18
  • All Genders

Study Summary

This is a multicenter investigator-initiated trial between Baylor-Scotts & White (BSW) and Methodist Health System (MHS). This study will be conducted via a retrospective review and a prospective patient registry. Patients who have undergone the ZPOEM procedure performed by the physicians listed in this protocol will be included, as well as patients who will have this procedure in the future. Data that will be collected at MHS will be entered into an Excel spreadsheet. Patient demographic information will be collected via a review of subjects' electronic medical records. Available patient outcomes will be collected via a review of electronic medical records. This review will be conducted from 1/1/2017 through 12/31/2025.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 18 years of age or older
  • Any patient of the physicians listed in this study who has undergone the ZPOEMprocedure to treat ZD at MHS
  • For prospective registry: Ability to give informed consent

Exclusion

Exclusion Criteria:

  • For prospective registry: Unable or not willing to provide informed consent

Study Design

Total Participants: 38
Treatment Group(s): 1
Primary Treatment: ZPOEM
Phase:
Study Start date:
June 25, 2021
Estimated Completion Date:
June 28, 2024

Study Description

This is a multicenter investigator-initiated trial between Baylor-Scotts & White (BSW) and Methodist Health System (MHS). This study will be conducted via a retrospective review and a prospective patient registry. Patients who have undergone the ZPOEM procedure performed by the physicians listed in this protocol will be included, as well as patients who will have this procedure in the future. Data that will be collected at MHS will be entered into an Excel spreadsheet. Patient demographic information will be collected via a review of subjects' electronic medical records. Available patient outcomes will be collected via a review of electronic medical records. This review will be conducted from 1/1/2017 through 12/31/2025.

To obtain the follow-up information, potential subjects will be identified using the same process described in the previous paragraph and will be contacted by a member of the institution's research team to answer questions about their symptoms post-surgery. These are listed in the ZPOEM Data Collection Sheet. These questions may be administered over the phone, via email, or by mail. Subjects enrolled in the patient registry will have follow-up data collected at 2-time points: 2 weeks post-op and 3 months post-op.

Primary endpoints and other variables to be collected are those listed on the ZPOEM Data Collection Sheet. Primary subject endpoints include, but are not limited to:

  • Dysphagia score(s) - depending on what is available in EMR

  • Weight gain following surgery

Connect with a study center

  • Methodist Dallas Medical Center

    Dallas, Texas 75203
    United States

    Site Not Available

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