Status:
UNKNOWN
ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
NeuroDx Development
Conditions:
Pseudotumor Cerebri
Eligibility:
All Genders
18+ years
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.
Detailed Description
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. Flow may be limited due to...
Eligibility Criteria
Inclusion
- 18 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 29 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04309383
Start Date
October 29 2019
End Date
January 1 2025
Last Update
June 1 2022
Active Locations (1)
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1
University of South Florida Department of Neurological Surgery and Brain Repair
Tampa, Florida, United States, 33606