Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device
Recruiting
N/AInterventional Study
Hydrocephalus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 – 80
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
29 (estimated)
Sponsor
Rhaeos, Inc. · Industry
Who this trial is looking for
This trial is looking for people with a CSF shunt who have frequent headaches. Participants will use a device to measure the flow of cerebrospinal fluid during headache and non-headache times over a month.
Are You a Good Fit for This Trial?
You may be able to join if
I have an existing ventriculoperitoneal CSF shunt
I have ongoing headaches for the past 3 months
I am at least 6 years old but not more than 80 years old
I can follow up for 30 days
I can communicate clearly in English
I have a suitable area of skin for the device
You may not be able to join if
I have more than one shunt catheter in the measurement area
My shunt is too deep to be felt
I have an open wound or swelling in the measurement area
I have had serious skin reactions to silicone adhesives
I might not be available for follow-up
I cannot reliably take measurements at home
I cannot place the device without help
I have been enrolled in this study before
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 headache and non-headache periods.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
1. Existing ventriculoperitoneal CSF shunt
2. Subject experiencing ongoing headaches including at least 15 headache days per month for the past 3 months
3. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which cross…
Inclusion Criteria:
1. Existing ventriculoperitoneal CSF shunt
2. Subject experiencing ongoing headaches including at least 15 headache days per month for the past 3 months
3. 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
4. Available for remote and in-person follow-up during the 30-day measurement period
5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
6. Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English
7. Subject is at least 6 years old but not more than 80 years old
Exclusion Criteria:
1. Presence of more than one distal shunt catheter in the study device measurement region
2. Shunt is not palpable due to depth or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
3. Presence of an interfering open wound or edema in the study device measurement region
4. Subject-reported history of serious adverse skin reactions to silicone-based adhesives
5. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
6. Investigator judges that the subject is unlikely to successfully take reliable measurements at home
7. Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
8. 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
9. Prior enrollment in this study
10. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.