Assessment of CSF Shunt Flow With Thermal Measurements A (NCT05015751) | Clinical Trial Compass
CompletedNot Applicable
Assessment of CSF Shunt Flow With Thermal Measurements A
United States44 participantsStarted 2021-08-25
Plain-language summary
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.
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* In…