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New treatment option for Hydrocephalus
Official title Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device
ClinicalTrials.gov ID: NCT06086561
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 80
You may be able to join if
- At least one existing ventricular CSF shunt (functional or non-functional, including "virtual off" and ligated, orphaned, abandoned, tied-off, or...
- Region(s) of intact skin overlying at least one unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is...
- Available for remote and in-person follow-up during the 30-day measurement period (for people 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 people using the...
- Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
You likely can't join if
- 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 people 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...
See the full eligibility 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 people 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 people 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
- 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 people 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...
- Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Rolling Meadows, Illinois, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Chicago, Illinois, United States; Rolling Meadows, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.