Clinical trial NCT05546996: EVD Drainage Data and Intracranial Pressure (ICP) Measurements
Official title: The Correlation Between FlowSense Flow Rate Measurements And: EVD Drainage Data and Intracranial Pressure (ICP) Measurements
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hydrocephalus
Keywords: EVD shunt
Hydrocephalus
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Rhaeos, Inc.
First posted: 2022-09-21
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase A: EVD drainage will be monitored by a digital video recorder capturing images of CSF dripping through the EVD drainage system graduated drip chamber.

Phase B: The EVD flow rate will be measured with FlowSense over a 20-minute period (FlowSense Flow Rate) (physician and patient blinded to device data), with patients receiving standard-of-care imaging and clinical observation. Simultaneously, a digital video recorder will be used to record video of CSF dripping through the EVD drainage system graduated drip chamber.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients with no external ventricular drains (EVDs).

Primary outcomes:
measure: Exploratory outcome
timeFrame: 1 year
Secondary outcomes:
measure: Suitability
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Samuel McClugage, MD
role: PRINCIPAL_INVESTIGATOR
References: