RecruitingNot Applicable

Formative Usability Assessment of Wireless Thermal Anisotropy Devices

United States145 participantsStarted 2023-09-29

Plain-language summary

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.

Who can participate

Age range

5 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device
. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
. Subject or caregiver can clearly communicate and document information in English
. Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision
. Subject is at least 5 years old but not more than 80 years old

Exclusion criteria

. Presence of an interfering open wound in the device application region
. Subject-reported history of adverse skin reactions to adhesives

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Exploratory device usability feedback

Timeframe: 2 hours

Trial details

NCT IDNCT06040697

SponsorRhaeos, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12

Contact for this trial

Anna Somera

855-814-3569 info@rhaeos.com

View on ClinicalTrials.gov More Hydrocephalus trials