Formative Usability Assessment of Wireless Thermal Anisotropy Devices

Recruiting now

Conditions studied: Hydrocephalus

In brief

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.

Key facts

Study ID

NCT06040697

Run by

Rhaeos, Inc.

People needed

145

Starts

2023-09-29

Expected to finish

2025-12-01

Last updated by the study team

2025-05-15

Who can join

Age: 5 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Rhaeos, Inc. — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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