ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Pseudotumor Cerebri
1 other identifier
observational
20
1 country
1
Brief Summary
The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with pseudotumor cerebri.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 29, 2019
CompletedFirst Submitted
Initial submission to the registry
March 12, 2020
CompletedFirst Posted
Study publicly available on registry
March 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedJune 1, 2022
May 1, 2022
4.6 years
March 12, 2020
May 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Specificity of ShuntCheck test
15 minutes
Negative Predictive Value of ShuntCheck test
15 minutes
Secondary Outcomes (2)
Specificity of performing ShuntCheck test twice
60 minutes
Negative Predictive Value of performing ShuntCheck test twice
60 minutes
Study Arms (1)
ShuntCheck
Participants will be administered the ShuntCheck diagnostic test.
Interventions
The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.
Eligibility Criteria
The study population will consist of asymptomatic PTC research subjects who have a VP shunt with a single ventricular catheter implanted for PTC and are visiting for routine care.
You may qualify if:
- years old or older Adult men or women who possess a VP shunt placed for PTC;
- Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent;
- Subjects will be asymptomatic visiting for routine care at 2-4 weeks post op
You may not qualify if:
- Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
- ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
- Presence of an interfering open wound or edema over any portion of the VP shunt.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- NeuroDx Developmentcollaborator
Study Sites (1)
University of South Florida Department of Neurological Surgery and Brain Repair
Tampa, Florida, 33606, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naomi Abel, MD
University of South Florida
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, College of Medicine Neurosurgery
Study Record Dates
First Submitted
March 12, 2020
First Posted
March 16, 2020
Study Start
October 29, 2019
Primary Completion
June 1, 2024
Study Completion
January 1, 2025
Last Updated
June 1, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
At present there is no plan to share any individual participant data.