Actively Recruiting
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device
Led by Rhaeos, Inc. · Updated on 2025-05-15
130
Participants Needed
4
Research Sites
106 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. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.
CONDITIONS
Official Title
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least one existing ventricular cerebrospinal fluid (CSF) shunt, functional or non-functional, including virtual off, ligated, orphaned, abandoned, tied-off, or fractured distal catheters
- Intact skin over at least one clearly identifiable chronically implanted ventricular shunt crossing the clavicle and suitable for device placement
- Availability for remote and in-person follow-up during the 30-day measurement period (for home use)
- Expected inpatient stay sufficient to complete required device measurements (for hospital use)
- Signed informed consent by participant or legally authorized representative
- Ability of participant or caregiver to communicate and document shunt symptoms clearly in English
- Verbal assent by minors aged 12 years and older who understand the study and can communicate their decision
- Age between 5 and 80 years inclusive
You will not qualify if you...
- Open wound or edema over any part of the shunt that would interfere with the device
- History of adverse skin reactions to adhesives reported by participant
- Likely loss to follow-up or inability to obtain clinical outcomes as judged by investigator
- Unlikely to take reliable measurements at home as judged by investigator (for home use)
- Inability of participant or caregiver to place the device without assistance as judged by investigator
- Use of study device would interfere with standard care, emergency surgery, or optimal healthcare
- Participation in other investigational procedural, pharmaceutical, or device studies that could affect data validity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Tampa Marriott Water Street
Tampa, Florida, United States, 33602
Actively Recruiting
2
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Withdrawn
3
MATTER
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Northwest Special Recreation Association
Rolling Meadows, Illinois, United States, 60008
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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