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Formative Usability Assessment of Wireless Thermal Anisotropy Devices

Rhaeos, Inc. · NCT06040697

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 5–80 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
145
US sites recruiting
1
Study start
September 29, 2023
Record last updated
May 15, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Thermal Anisotropy

Conditions: Hydrocephalus

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Rhaeos, Inc.

    Chicago, IL 60654

    Site contact: Anna Somera · clinical@rhaeos.com

Study contacts (from the official record)

  • Anna Somera · 855-814-3569 · info@rhaeos.com
Formative Usability Assessment of Wireless Thermal Anisotropy Devices (NCT06040697) | Bored Studies