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Retrospective cohort for Zenker Diverticulum (ZPOEM Trial)

N/A

Waitlist Available

Led By Prashant Kedia, MD

Research Sponsored by Methodist Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up january 2017 to december 2025

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Zenker Diverticulum

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ january 2017 to december 2025

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~january 2017 to december 2025

This trial's timeline: 3 weeks for screening, Varies for treatment, and january 2017 to december 2025 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Retrospective cohortExperimental Treatment1 Intervention

Any patient of the physicians listed in this study who has undergone the ZPOEM procedure to treat ZD at Methodist Health System

Group II: Prospective cohortExperimental Treatment1 Intervention

Any patient of the physicians listed in this study who has undergone the ZPOEM procedure to treat ZD at Methodist Health System and has agreed to be follow-up post-procedure.

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