CompletedNot Applicable

Assessment of CSF Shunt Flow in an Outpatient Setting with a Thermal Measurement Device

United States20 participantsStarted 2024-12-10

Plain-language summary

This study collects exploratory data using a non-invasive device for assessing CSF shunt flow using thermal anisotropy measurements. Patients with an existing implanted ventricular CSF shunt will be enrolled into either a prospective (study device) or retrospective (no study device) cohort to gather data on health resource utilization, quality-of-life, and study device measurements.

Who can participate

SexALL

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Inclusion criteria

✓. Existing ventricular cerebrospinal fluid shunt
✓. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
✓. Subject available for 2 week follow-up
✓. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device (Cohort A only)

Exclusion criteria

✕. Presence of more than one distal shunt catheter in the study device measurement region
✕. Presence of an interfering open wound or edema in the study device measurement region
✕. Subject-reported history of serious adverse skin reactions to silicone-based adhesives
✕. Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject

What they're measuring

Quality of Life

Timeframe: 14 days

Trial details

NCT IDNCT06753929

SponsorRhaeos, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-05

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