NCT06086561 · Rhaeos, Inc.
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device
What this study is about
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.
View original scientific description
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.
Interventions
DEVICE
Thermal Anisotropy Measurement Device
The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.
Primary outcome measures
Skin Temperature
Time frame: up to 90 days
Exploratory assessment of thermal skin measurements taken with the study device
Acceleration
Time frame: up to 90 days
Exploratory assessment of accelerometer measurements taken with the study device
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- At least one existing ventricular CSF shunt (functional or non-functional, including "virtual off" and ligated, orphaned, abandoned, tied-off, or fractured distal catheters)
- Region(s) of intact skin overlying at least one unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
- Available for remote and in-person follow-up during the 30-day measurement period (for subjects using the study device at home)
- Subject is expected to remain in an inpatient setting for sufficient time to complete all required study device measurements (for subjects using the device in an inpatient hospital setting)
- Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English
- Verbal assent by minors 12 years of age and older who are able to understand the study and communicate their decision
- Patient is at least 5 years old but not more than 80 years old
Exclusion criteria
- 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
- Investigator judges that the subject is unlikely to successfully take reliable measurements at home (for subjects using the study device at home)
- Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
- 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
- Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Where
- Tampa, Florida
- Chicago, Illinois
- Rolling Meadows, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 15, 2025 · Source of record for eligibility and locations