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Formative Usability Assessment of Wireless Thermal Anisotropy Devices

Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts

Who can join

Ages 5 to 80 · All sexes · Healthy volunteers welcome

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

About the study

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.

What is being tested

• Thermal Anisotropy (device)

Sponsor: Rhaeos, Inc. · Participants: 145 · Started: Sep 29, 2023

Contact the study team

• Anna Somera · Phone: 855-814-3569

Official record on ClinicalTrials.gov — NCT06040697

Locations in the U.S.

Conditions

• Hydrocephalus

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.