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

NCT06753929 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-02-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Rhaeos, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2025-02-05
Completion
2025-02-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06753929 on ClinicalTrials.gov