FlowSense® for Hydrocephalus

Overseen By Anna Lisa Somera

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Rhaeos, Inc.

Disqualifiers: Multiple shunt catheters, Open wound, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with an existing implanted ventricular CSF shunt will be evaluated with the study device in an outpatient setting to determine the negative predictive value (NPV; Part 1, blinded) and explore changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits (Part 2, unblinded).

Eligibility Criteria

This trial is for people aged 2 or older with a working ventricular cerebrospinal fluid shunt and no current concerns for malfunction. They must have intact skin where the device will be placed and either give consent themselves or through a guardian.

Inclusion Criteria

I have a shunt for draining fluid from my brain.

I am at least 2 years old.

I have a clear area of skin over my long-term ventricular shunt.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational, part 1 (blinded)

Subjects with an existing implanted ventricular CSF shunt are evaluated with the study device to determine the negative predictive value (NPV) in a blinded fashion.

Up to 7 days

Diagnostic, part 2 (unblinded)

Exploration of changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits with the study device in an unblinded fashion.

Follow-up

Participants are monitored for safety and effectiveness after treatment, including intraoperative observations for any surgery performed per the standard of care.

7 days

Treatment Details

Interventions

• FlowSense®

Trial Overview The study tests FlowSense®, a non-invasive sensor to check cerebrospinal fluid flow in patients with shunts. It aims to determine its accuracy (Part 1) and impact on routine follow-up care (Part 2).

Participant Groups

Group I: Observational, part 1 (blinded) Experimental Treatment 1 Intervention

Group II: Diagnostic, part 2 (unblinded) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Rhaeos, Inc.

Lead Sponsor

Trials

11

Recruited

690+