Formative Usability Assessment of Wireless Thermal Anisotropy Devices

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.

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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rhaeos, Inc.

Chicago, Illinois, 60654, United States

Location status: Recruiting

Location contact

Anna Somera

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device
Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
Subject or caregiver can clearly communicate and document information in English
Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision
Subject is at least 5 years old but not more than 80 years old

Exclusion criteria

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

Treatment and study plan

Thermal Anisotropy

Device

Usability assessment observation.

Other names: FlowSense

Primary outcomes

Exploratory device usability feedback

Time frame: 2 hours

Identification of usability risks [unscored]

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Somera

CONTACT

[email protected]

855-814-3569

Sponsors and collaborators

Lead sponsor

Rhaeos, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Sep 15, 2023
Registry last updated: May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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