CompletedNot Applicable

Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device

United States52 participantsStarted 2024-07-25

Plain-language summary

This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.

Who can participate

SexALL

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Inclusion criteria

✓. A ventricular CSF shunt with a region of overlying intact skin 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)
✓. Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
✓. Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision

Exclusion criteria

✕. Presence of an interfering open wound or edema in the study device measurement area
✕. Patient-reported history of serious adverse skin reactions to silicone-based adhesives
✕. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
✕. Patient or caregiver report of new or worsening symptoms of a possible shunt malfunction in the prior 7 days
✕. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

What they're measuring

Study Device Sensitivity

Timeframe: Approximately 1 hour

Study Device Specificity

Timeframe: Approximately 1 hour

Trial details

NCT IDNCT06524492

SponsorRhaeos, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-07-27

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