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NCT06040697 Clinical Trial

Formative Usability Assessment of Wireless Thermal Anisotropy Devices

Hydrocephalus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06040697
Other study ID # 2023-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 29, 2023
Est. completion date December 2024

Study information
Verified date May 2024
Source Rhaeos, Inc.
Contact Anna Somera
Phone 855-814-3569
Email info@rhaeos.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 145
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Thermal Anisotropy
Usability assessment observation.

Locations
Country Name City State
United States Rhaeos, Inc. Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Rhaeos, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Exploratory device usability feedback Identification of usability risks [unscored] 2 hours
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