Recruiting NCT04011566
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ShuntCheck.
- Who it may be relevant to
- Registry conditions: Hydrocephalus, Normal Pressure. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 asymptomatic normal pressure hydrocephalus.
Interventions
- Diagnostic test ShuntCheck
The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.
Primary outcome measures
- Specificity of ShuntCheck test [Time frame: 15 minutes]
- Negative Predictive Value of ShuntCheck test [Time frame: 15 minutes]
Secondary outcome measures (2)
- Specificity of performing ShuntCheck test twice [Time frame: 60 minutes]
- Negative Predictive Value of performing ShuntCheck test twice [Time frame: 60 minutes]
Eligibility criteria
Inclusion criteria
- Asymptomatic men or women 40 years old or older and have a ventriculoperitoneal shunt placed for normal pressure hydrocephalus and are visiting for routine care.
- Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker capable of providing valid, signed informed consent.
Exclusion criteria
- 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 ventriculoperitoneal shunt.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of South Florida Department of Neurological Surgery and Brain Repair — Tampa
Identifiers
NCT: NCT04011566 · Pro00040697