Hydrocephalus
Conditions
Brief summary
This study collects data using non-invasive devices for assessing CSF shunt flow using thermal anisotropy measurements in a prospective study setting. The study will collect data to compare measurements from flowing shunts, non-flowing shunts, and off-shunt locations.
Interventions
DEVICEFlowSense
This study collects data using non-invasive devices for assessing CSF shunt flow using thermal anisotropy measurements in a prospective study setting. The study will collect data to compare measurements from flowing shunts, non-flowing shunts, and off-shunt locations.
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 serious adverse skin reactions to silicone-based adhesives 3. 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 4. 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 |
|---|---|---|
| Correlation of measurement data | Approximately 1 hour | Correlation between measurements from flowing shunts, non-flowing shunts, and off-shunt locations. |
Countries
United States
Outcome results
None listed