Evaluation of Peroral Endoscopic Myotomy to Treat Zenker's Diverticulum

Zenker Diverticulum Clinical Trial

— ZPOEM  

Official title:

Evaluation of Peroral Endoscopic Myotomy to Treat Zenker's Diverticulum

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05157984
• Other study ID #: 031.GID.2021.D
• Secondary ID: 2020.11.16
• Status: Enrolling by invitation
• Start date: June 25, 2021
• Est. completion date: June 28, 2024

Study information

• Verified date: March 2024
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 38
• Est. completion date: June 28, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diverticulum
• Zenker Diverticulum

Intervention

Procedure:
• ZPOEM
Zenker's diverticulum management by Per oral endoscopic myotomy (POEM)

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Methodist Health System	Baylor Scott and White Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Follow up of patients who had the 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.	June 2021 to December 2025