Formative Usability Assessment of Wireless Thermal Anisotropy Devices

Rhaeos

Status: Enrolling

Conditions: Hydrocephalus

Treatments: Device: Thermal Anisotropy

Study type: Observational

Funder types: Industry

Identifiers

NCT06040697

2023-02

Details and patient eligibility

About

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.

Enrollment: 145 estimated patients

Sex: All

Ages: 5 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

145 participants in 1 patient group

Usability Assessment Cohort

Description:

No interventions administered. Device usability assessment only.

Treatment:

Device: Thermal Anisotropy