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Recruiting NCT06040697

Formative Usability Assessment of Wireless Thermal Anisotropy Devices

— Observational Hydrocephalus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thermal Anisotropy.
Who it may be relevant to
Registry conditions: Hydrocephalus. Basic parameters: 5 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Device Thermal Anisotropy
    Usability assessment observation.

Primary outcome measures

  • Exploratory device usability feedback [Time frame: 2 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

United States · 1 center
  • Rhaeos, Inc. — Chicago

Identifiers

NCT: NCT06040697 · 2023-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗