Hydrocephalus
Conditions
Brief summary
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of known non-functional and functional implanted shunts will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
Interventions
DEVICEFlowSense
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of known non-functional and functional implanted shunts will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
Sponsors
Rhaeos, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. At least one existing ventricular CSF shunt, functional or non-functional (including an adjustable valve set to virtual off, ligated shunt, uncorrected distal catheter disconnection or fracture, distal catheter fragment left in place during shunt surgery, or indication that the shunt is otherwise non-functional), with a region of overlying intact skin appropriate in size for application of the study device 2. If more than one distal shunt catheter is present, at least one distal shunt catheter is at least 2 cm away from any other distal shunt catheter in the device measurement region 3. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 4. Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 5. Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision
Exclusion criteria
1. Presence of an interfering open wound or edema in the FlowSense device measurement area 2. Patient-reported history of adverse skin reactions to adhesives 3. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired 4. New or worsening symptoms of a possible shunt malfunction in the prior 7 days 5. Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject 6. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Device Sensitivity | Up to 1 hour | Study device sensitivity will be calculated as TP / (TP + FN). |
| Study Device Specificity | Up to 1 hour | Study device specificity will be calculated as TN / (TN + FP) |
Countries
United States
Outcome results
None listed