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Official title Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device
ClinicalTrials.gov ID: NCT07050628
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 over multiple measurements performed by a study subject during activities of daily living and sleep
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 21
You may be able to join if
- Existing ventricular CSF shunt
- (Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure
- (Cohort B) A shunt revision in the previous 7 days and the investigator judges that the patient will likely be discharged within 4 days of the...
- Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is...
- 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
- Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
- Presence of an interfering open wound or edema in the study device measurement region
- Subject-reported history of serious adverse skin reactions to silicone-based 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
- Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
See the full eligibility criteria
- Existing ventricular CSF shunt
- (Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure
- (Cohort B) A shunt revision in the previous 7 days and the investigator judges that the patient will likely be discharged within 4 days of the enrollment date
- Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
- Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- Subject is at least 5 years old but \< 22 years old
- Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
- Presence of an interfering open wound or edema in the study device measurement region
- Subject-reported history of serious adverse skin reactions to silicone-based 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
- 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...
- Prior enrollment in this study
- 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
- Chicago, Illinois, United States
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Richmond, Virginia, 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.