Actively Recruiting

Phase Not Applicable
Age: 1Year - 21Years
All Genders
NCT05546996

EVD Drainage Data and Intracranial Pressure (ICP) Measurements

Led by Baylor College of Medicine · Updated on 2026-03-25

24

Participants Needed

1

Research Sites

185 weeks

Total Duration

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Sponsors

B

Baylor College of Medicine

Lead Sponsor

R

Rhaeos, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Rhaeos, Inc. is initially targeting hydrocephalus, a life threatening condition caused by an abnormal accumulation of cerebrospinal fluid (CSF). Implantable shunts, the gold standard treatment, often fail, leading to multiple trips to the emergency room and repeat surgeries. There is no technology available today that can easily assess CSF flow in shunts wirelessly, bedside, and without capital equipment until now. FlowSense, is a wireless, noninvasive thermal flow sensor that can be mounted on a patient's neck overlying the shunt to detect the presence and magnitude of CSF. Similar in size to a bandage, it is composed of soft, silicone with no hard edges. Data is wirelessly transmitted to a custom designed mobile app. With FlowSense, monitoring of shunt function can occur in clinics, in-patient settings, and emergency departments, thereby reducing unnecessary imaging, hospital length of stay, and readmission costs.

CONDITIONS

Official Title

EVD Drainage Data and Intracranial Pressure (ICP) Measurements

Who Can Participate

Age: 1Year - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with one or more existing external ventricular drains (EVDs).
Not Eligible

You will not qualify if you...

  • Patients with no external ventricular drains (EVDs).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

S

Samuel McClugage, MD

CONTACT

S

Sarah Martinez

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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