Home › Hydrocephalus › NCT05546996
EVD Drainage Data and Intracranial Pressure (ICP) Measurements
The Correlation Between FlowSense Flow Rate Measurements and: EVD Drainage Data and Intracranial Pressure (ICP) Measurements
Who can join
Ages 1 to 21 · All sexes
Full eligibility criteria
Inclusion Criteria: * Patients with one or more existing external ventricular drains (EVDs). Exclusion Criteria: * Patients with no external ventricular drains (EVDs).
About the study
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.
What is being tested
- FlowSense (device)
Sponsor: Baylor College of Medicine · Participants: 24 · Started: Jul 11, 2023
Contact the study team
- Samuel McClugage, MD · Phone: 8328223950
- Sarah Martinez · Phone: 8328223950
Official record on ClinicalTrials.gov — NCT05546996
Locations in the U.S.
| Texas | Texas Children's Hospital, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.