Actively Recruiting
Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts
Led by Rhaeos, Inc. · Updated on 2025-05-15
145
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the usability of wireless thermal anisotropy devices that measure flow in cerebrospinal fluid shunts in people with hydrocephalus. The study focuses on collecting feedback to help improve future device designs and does not involve administering treatments or interventions. Participants include both children and adults who have existing ventricular cerebrospinal fluid shunts. The study involves non-invasive measurements of shunt flow using the thermal anisotropy device. Participants will not receive any treatment as part of the study; instead, researchers will observe how easily participants or their caregivers can use the device and understand its functions. This usability assessment will gather data through observed tasks and comprehension questions. Participants will be involved for approximately two hours during which researchers will collect exploratory device usability feedback. The study includes assessments of the participant's ability to communicate and consent, with verbal assent required from minors aged 12 and older. The study team will monitor for any adverse skin reactions related to the device adhesives and ensure the safety of the application area. The total participation time is brief and focused on device interaction and feedback collection.
CONDITIONS
Brief Title
Formative Usability Assessment of Wireless Thermal Anisotropy Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Existing ventricular CSF shunt with intact skin over the shunt catheter area suitable for device application
- Signed informed consent by the participant or legal guardian
- Ability to communicate and document information clearly in English
- Verbal assent by minors age 12 and older who understand the study
- Age between 5 and 80 years old
You will not qualify if you...
- Presence of an open wound in the device application area
- History of adverse skin reactions to adhesives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 2 hours
Participants undergo usability assessment observation of the wireless thermal anisotropy device measuring flow in cerebrospinal fluid shunts.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Rhaeos, Inc.
Chicago, Illinois, United States, 60654
Actively Recruiting
Research Team
A
Anna Somera
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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