Clinical trial Recruiting at 1 site Interventional Ages 1 Year to 21

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.

More Hydrocephalus trials

Quick facts

Study typeInterventional
Ages1 Year to 21 Years
SexAll
Enrollment24 (estimated)
SponsorBaylor College of Medicine
Academic / other
Locations1 site (Houston, Texas)
StatusRecruiting
StartedJuly 11, 2023
Main results expectedJanuary 30, 2027
Study endsJanuary 30, 2027
Registry record updatedMarch 25, 2026
Trial IDNCT05546996 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

  • 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.