EVD Drainage Data and Intracranial Pressure (ICP) Measurements

Not Applicable

Recruiting

• Conditions: Hydrocephalus
• Interventions: Device: FlowSense

• Registration Number: NCT05546996
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-21
• Study Start: 2023-07-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21
• Primary Completion: 2026-01-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

• Patients with no external ventricular drains (EVDs).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase B	FlowSense	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

Primary Outcome Measures

Name	Time	Method
Exploratory outcome	1 year	Number of participants with accurate cerebrospinal flow rate measurements (measured through the FlowSense device), EVD drainage, intracranial pressure measurements. This will be measured using a video camera. We will see the changes in flow for every 20 minutes in the recording. However, this project is not intended to be statistically powered

Secondary Outcome Measures

Name	Time	Method
Suitability	1 year	Number of times the video recording works properly by visually playing back the videos.

Trial Locations

Locations (1)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States