Wireless monitoring of cerebrospinal fluid flow in hydrocephalus patients
Official title: The Correlation Between FlowSense Flow Rate Measurements and: EVD Drainage Data and Intracranial Pressure (ICP) Measurements
Run by Baylor College of Medicine · NCT05546996 · Data updated 2026-11-12
This study is testing a new wireless device that helps monitor fluid flow in the brains of people with hydrocephalus to see if it can improve their care and reduce hospital visits.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Year to 21 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | July 11, 2023 |
| Main results expected | January 30, 2027 |
| Study ends | January 30, 2027 |
| Registry record updated | March 25, 2026 |
| Trial ID | NCT05546996 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with one or more existing external ventricular drains (EVDs).
✕Probably not a fit
Patients without external ventricular drains (EVDs) will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial focuses on the use of FlowSense, a noninvasive thermal flow sensor designed to monitor cerebrospinal fluid (CSF) flow in patients with hydrocephalus who have external ventricular drains (EVDs). The device is a soft, silicone patch that can be placed on the neck over the shunt, allowing for real-time data transmission to a mobile app. By providing a wireless and bedside assessment of shunt function, the study aims to reduce unnecessary imaging, hospital stays, and readmission rates associated with shunt failures. The trial seeks to improve patient outcomes by enabling better monitoring and management of this life-threatening condition.
Why it matters
Potential benefit: If successful, this technology could significantly enhance the management of hydrocephalus, reducing emergency visits and improving patient quality of life.
How similar studies have gone: While this approach is innovative, similar studies have not been widely reported, making this a novel application in the field.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with one or more existing external ventricular drains (EVDs). Exclusion Criteria: * Patients with no external ventricular drains (EVDs).
Where it's running
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Texas Children's Hospital
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Samuel McClugage, MD — Baylor College of Medicine
- Study coordinator: Samuel McClugage, MD
- Email: mcclugag@bcm.edu
- Phone: 8328223950
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This will test a small, wireless skin sensor to see if it can detect cerebrospinal fluid (CSF) flow through implanted shunts in children and adults with stable hydrocephalus.
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See if a wireless thermal device can measure CSF shunt flow during daily activities and sleep
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.