Formative Usability Assessment of Wireless Thermal Anisotropy Devices

Launched by RHAEOS, INC. · Sep 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device that measures how well a shunt is working in patients with hydrocephalus, a condition where excess fluid builds up in the brain. The goal is to gather information on how easy this device is to use and understand, which will help improve its design in the future. Researchers will observe participants using the device and ask questions to ensure they understand how it works.

To participate in this study, you need to have a working ventricular shunt and be between 5 and 80 years old. It's important that you or your caregiver can communicate in English and understand the study details. Participants can expect to help researchers learn more about this device in a safe and non-invasive way, meaning no needles or surgeries are involved. If you have any open wounds near the shunt or have had bad reactions to adhesives in the past, you won't be eligible to join. This trial is currently recruiting, and everyone is welcome to apply, regardless of gender.

Gender

ALL

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 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