Assessment of CSF Shunt Flow With Thermal Measurements B

Completed

Conditions studied: Hydrocephalus

In brief

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.

Key facts

Study ID

NCT05432986

Run by

Rhaeos, Inc.

People needed

141

Starts

2022-07-07

Expected to finish

2023-11-10

Last updated by the study team

2025-02-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Existing ventriculoperitoneal CSF shunt on which the patient is dependent
• 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
• 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 seven days
• 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)
• Verbal assent by minors four years of age and older who are able to understand the study and communicate their decision

You may not qualify if…

• 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 main study 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

Where it is running

• UCSF Benioff Children's Hospital — Oakland, California, United States
• UCSF Benioff Children's Hospital — San Francisco, California, United States
• Lurie Children's Hospital — Chicago, Illinois, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Illinois Chicago — Chicago, Illinois, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Lenox Hill Hospital — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Dayton Children's Hospital — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

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