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Clinical Trials/NCT05157984
NCT05157984
Enrolling By Invitation
Not Applicable

Evaluation of Peroral Endoscopic Myotomy to Treat Zenker's Diverticulum

Methodist Health System1 site in 1 country38 target enrollmentJune 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Zenker Diverticulum
Sponsor
Methodist Health System
Enrollment
38
Locations
1
Primary Endpoint
Retrospective chart review / Compartive analyses; t-tests and Wilcoxon-Mann-Whiteney Test; Chi-square or Fisher's exact test; and Pearson correlation coeffecient or Spearman's rank-order correlation
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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

Registry
clinicaltrials.gov
Start Date
June 25, 2021
End Date
June 28, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Retrospective chart review / Compartive analyses; t-tests and Wilcoxon-Mann-Whiteney Test; Chi-square or Fisher's exact test; and Pearson correlation coeffecient or Spearman's rank-order correlation

Time Frame: January 2017 to December 2025

Retrospective review of patient records who have had ZPOEM procedure, compartive analyses will be performed by employing statistical tests such as t-tests and Wilcoxon-Mann-Whiteney Test; Chi-square or Fisher's exact test; and Pearson correlation coeffecient or Spearman's rank-order correlation depdening on the data distribution. Multivariate analyses will be employed with a p-value \<0.05 will indicate statistical significance.

Secondary Outcomes

  • Prospective follow-up of patients/ Compartive analyses; t-tests and Wilcoxon-Mann-Whiteney Test; Chi-square or Fisher's exact test; and Pearson correlation coeffecient or Spearman's rank-order correlation(June 2021 to December 2025)

Study Sites (1)

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