Assessment of CSF Shunt Flow With Thermal Measurements A

Rhaeos

Status

Completed

Conditions

Hydrocephalus

Treatments

Device: Thermal Anisotropy Measurement Device

Study type

Observational

Funder types

Industry

Identifiers

NCT05015751

2020-01

Details and patient eligibility

About

This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.

Full description

Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing shunt malfunction symptoms will be recruited by the clinical investigators at each investigational site in accordance with the inclusion and exclusion criteria. Assessment of shunt flow will be performed non-invasively with the study device; physician and clinical staff will be blinded to the device result. Standard-of-care assessment of shunt function will be performed and surgical intervention will occur based on the judgement of the treating neurosurgeon without the use of study device data. This trial will evaluate the ability of the study device to identify shunt malfunctions.

Enrollment

44 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Existing ventriculoperitoneal CSF shunt
At least one symptom of shunt malfunction as determined by the investigator, including seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function
Suspicion of shunt obstruction warrants the performance of a test for this condition in the investigator's judgement
Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
Available for follow-up for up to fourteen days
Signed informed consent by patient or a parent, legal guardian, health care agent, or legally authorized representative.
Verbal assent by minors four years of age and older who are able to understand the study and communicate their decision

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
Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed
Presence of an interfering open wound or edema over any portion of the shunt
Patient-reported history of adverse skin reactions to adhesives
Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject
Prior enrollment in this study (multiple enrollments of the same patient are disallowed)
Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study