Assessment of CSF Shunt Flow With Thermal Measurements B

a study on Hydrocephalus

Summary

Location
at Oakland, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device, Phase B

Details

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.

Keywords

Hydrocephalus, Thermal Anisotropy Measurement Device

Eligibility

You can join if…

  1. Existing ventriculoperitoneal CSF shunt on which the patient is dependent
  2. At least one symptom of shunt malfunction as determined by the investigator, such as but not limited to 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
  3. Suspicion of shunt obstruction warrants the performance of a test for this condition in the investigator's judgement
  4. 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
  5. Available for follow-up for up to seven days
  6. Signed informed consent by patient or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol)
  7. Verbal assent by minors four years of age and older who are able to understand the study and communicate their decision

You CAN'T join if...

  1. 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
  2. Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed
  3. Presence of an interfering open wound or edema over any portion of the shunt
  4. Patient-reported history of adverse skin reactions to adhesives
  5. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
  6. Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject
  7. Prior enrollment in this study (multiple main study enrollments of the same patient are disallowed)
  8. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Locations

  • UCSF Benioff Children's Hospital accepting new patients
    Oakland California 94609 United States
  • UCSF Benioff Children's Hospital accepting new patients
    San Francisco California 94158 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rhaeos, Inc.
ID
NCT05432986
Study Type
Observational
Participants
Expecting 100 study participants
Last Updated
Contact us about this trial