NCT06753929

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

Assessment of Flow in Cerebrospinal Fluid Shunts with a Wireless Thermal Anisotropy Measurement Device During Routine Outpatient Surveillance Visits

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Rhaeos, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hydrocephalus

Interventions

Type	Name	Description
DEVICE	wireless wearable thermal anisotropy measurement device	non-invasive device used for assessing CSF shunt flow via thermal anisotropy measurements in a routine outpatient clinic setting

Timeline

• Start date: 2024-12-10
• Primary completion: 2025-02-05
• Completion: 2025-02-05
• First posted: 2024-12-31
• Last updated: 2025-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study