EVD Drainage Data and Intracranial Pressure (ICP) Measurements

ConditionHydrocephalus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-21
SponsorBaylor College of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

Patients with one or more existing external ventricular drains (EVDs).

Disqualifiers

Patients with no external ventricular drains (EVDs).

Trial design

Treatments tested in this trial

  • FlowSense

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators