Evaluation of Peroral Endoscopic Myotomy to Treat Zenker's Diverticulum
NCT ID: NCT05157984
Last Updated: 2024-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
38 participants
OBSERVATIONAL
2021-06-25
2024-06-28
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Retrospective cohort
Any patient of the physicians listed in this study who has undergone the ZPOEM procedure to treat ZD at Methodist Health System
ZPOEM
Zenker's diverticulum management by Per oral endoscopic myotomy (POEM)
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.
ZPOEM
Zenker's diverticulum management by Per oral endoscopic myotomy (POEM)
Interventions
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ZPOEM
Zenker's diverticulum management by Per oral endoscopic myotomy (POEM)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Baylor Scott and White Health
OTHER
Methodist Health System
OTHER
Responsible Party
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Principal Investigators
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Prashant Kedia, MD
Role: PRINCIPAL_INVESTIGATOR
Methodist Health System
Locations
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Methodist Dallas Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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2020.11.16
Identifier Type: OTHER
Identifier Source: secondary_id
031.GID.2021.D
Identifier Type: -
Identifier Source: org_study_id
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