Actively Recruiting
Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device
Led by Rhaeos, Inc. · Updated on 2025-05-30
29
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Existing ventriculoperitoneal cerebrospinal fluid shunt
- Experiencing ongoing headaches with at least 15 headache days per month for the past 3 months
- Intact skin over a clearly palpable ventricular shunt crossing the clavicle suitable for device placement
- Available for remote and in-person follow-up during the 30-day measurement period
- Signed informed consent by subject or legal representative
- Ability to communicate and document shunt symptoms clearly in English
- Age between 6 and 80 years old
You will not qualify if you...
- More than one distal shunt catheter in the measurement region
- Shunt not palpable or deeper than 4 mm at the device placement site
- Open wound or swelling in the device measurement area
- History of serious skin reactions to silicone-based adhesives
- Likely to be lost to follow-up or have unobtainable clinical outcomes
- Unlikely to take reliable home measurements
- Unable to place device without assistance
- Device use would interfere with standard care or emergency surgery
- Prior enrollment in this study
- Participation in other investigational studies affecting valid data collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rhaeos, Inc
Chicago, Illinois, United States, 60642
Actively Recruiting
Research Team
A
Anna Somera
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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