This study is testing a new, non-invasive device called FlowSense® that can check the flow in cerebrospinal fluid (CSF) shunts. These shunts are used to treat hydrocephalus, a condition where there's too much fluid around the brain. The FlowSense® device is placed on your skin over your existing shunt. The study aims to see how well FlowSense® can correctly identify when a shunt is working properly (its negative predictive value). You might be able to join if you are at least 2 years old, have an existing CSF shunt, and have a suitable area of skin over your shunt for the device. The study is currently unclear about its recruitment status.

Study design

This is an interventional study planning to enroll 60 participants. It involves a blinded part (Part 1) and an unblinded part (Part 2).

What's involved

You would have the FlowSense® device placed on your skin over your shunt during an outpatient visit. The study will also look at changes in imaging, healthcare use, and visit length during your routine follow-up appointments.

Compensation

Not stated in the trial record.

Follow-up

The primary outcome, negative predictive value, is measured up to 7 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.