Formative Usability Assessment of Wireless Thermal Anisotropy Devices
Recruiting
Observational Study
Hydrocephalus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
5 – 80
Sex
Any
Study type
Observational
Participants needed
145 (estimated)
Sponsor
Rhaeos, Inc. · Industry
Who this trial is looking for
This trial is looking for people with an existing ventricular shunt. Participants will help test a wireless device that measures shunt flow without surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I have an existing ventricular CSF shunt.
I can communicate and document information in English.
I am at least 5 years old but not more than 80 years old.
I agree to participate or my parent/guardian has given consent.
I understand the study and can give verbal assent if I am a minor 12 years or older.
You may not be able to join if
I have an open wound in the area where the device will be applied.
I have a history of bad skin reactions to adhesives.
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.
Measurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device
2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to loc…
Inclusion Criteria:
1. Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device
2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
3. Subject or caregiver can clearly communicate and document information in English
4. Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision
5. Subject is at least 5 years old but not more than 80 years old
Exclusion Criteria:
1. Presence of an interfering open wound in the device application region
2. Subject-reported history of adverse skin reactions to adhesives
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