Formative Usability Assessment of Wireless Thermal Anisotropy Devices

Description

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.

Conditions

Hydrocephalus

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Study Overview

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Study Details

Study overview

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.

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

Formative Usability Assessment of Wireless Thermal Anisotropy Devices

Condition
Hydrocephalus
Intervention / Treatment

-

Contacts and Locations

Chicago

Rhaeos, Inc., Chicago, Illinois, United States, 60654

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

5 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Rhaeos, Inc.,

Study Record Dates

2024-12