Evaluation of Peroral Endoscopic Myotomy to Treat Zenker's Diverticulum
ZPOEM
2 other identifiers
observational
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2021
CompletedStudy Start
First participant enrolled
June 25, 2021
CompletedFirst Posted
Study publicly available on registry
December 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2024
CompletedMarch 27, 2024
March 1, 2024
3 years
June 10, 2021
March 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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.
January 2017 to December 2025
Secondary Outcomes (1)
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 Arms (2)
Retrospective cohort
Any patient of the physicians listed in this study who has undergone the ZPOEM procedure to treat ZD at Methodist Health System
Prospective cohort
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.
Interventions
Zenker's diverticulum management by Per oral endoscopic myotomy (POEM)
Eligibility Criteria
Patients diagnosed with Zenker's diverticulum (ZD) and who have undergone the ZPOEM procedure, as well as patients who will have this procedure in the future
You may qualify if:
- 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
You may not qualify if:
- For prospective registry: Unable or not willing to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Methodist Health Systemlead
- Baylor Scott and White Healthcollaborator
Study Sites (1)
Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prashant Kedia, MD
Methodist Health System
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2021
First Posted
December 15, 2021
Study Start
June 25, 2021
Primary Completion
June 28, 2024
Study Completion
June 28, 2024
Last Updated
March 27, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
Participant data will be shared only with Baylor, Scott \& White. All data will be de-identified and in compliance with the Data User Agreement in place between both institutions.