EVD Drainage Data and Intracranial Pressure (ICP) Measurements (RHAEOS)

Baylor College of Medicine

Status: Enrolling

Conditions: Hydrocephalus

Treatments: Device: FlowSense

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05546996

H-51840

Details and patient eligibility

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.

Full description

Hydrocephalus is caused by excess cerebrospinal fluid in the brain that can lead to lethargy, seizures, and comas. There is no cure for it nor is there any way to prevent it from happening. Affecting 1M Americans today, treatment costs the healthcare system >$2B per year. Neurosurgically implanted shunts, the standard treatment, often fail. Patients with failed shunts show nonspecific symptoms, including headaches, dizziness and nausea. CTs and MRIs are used for diagnosis, but are inconclusive, expensive, and often lead to unnecessary admissions.

Rhaeos, Inc. is a VC backed, clinical stage medical device company developing FlowSense, a patent protected platform technology and a noninvasive wireless, wearable skin patch that can assess and monitor fluid flow subdermally throughout the body. The company 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 1 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients with no external ventricular drains (EVDs).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Phase A:

No Intervention group

Description:

Establish suitability of digital video recording system for quantifying CSF drainage into an EVD drainage system.

Phase B

Other group

Description:

Exploratory study to generate initial data on the correlation between FlowSense flow rate measurements (FlowSense Flow Rate) and: A) EVD drainage data, quantified via video recording; B) intracranial pressure (ICP) measurements

Treatment:

Device: FlowSense