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

The Correlation Between FlowSense Flow Rate Measurements and: EVD Drainage Data and Intracranial Pressure (ICP) Measurements

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.

Study Overview

• Status: Recruiting
• Conditions: Hydrocephalus
• Intervention / Treatment: Device: FlowSense

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samuel McClugage, MD; Phone Number: 8328223950; Email: mcclugag@bcm.edu
• Study Contact Backup: Name: Sarah Martinez; Phone Number: 8328223950; Email: sxwisor@texaschildrens.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Texas Children's Hospital
      • Contact: Sarah Martinez, MPH; Email: sxwisor@texaschildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with no external ventricular drains (EVDs).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Phase A: Establish suitability of digital video recording system for quantifying CSF drainage into an EVD drainage system.
Other: Phase B; 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	Device: FlowSense; Patients will have one or more existing external ventricular drains (EVDs). Phase B patients will additionally have an accessible (shaved) region of skin >3 cm x 3 cm overlaying the EVD tubing. Clinical data to be collected include: 1) total drainage volume1 over the 20-minute measurement period; 2) handheld ultrasound measurement of skin thickness2 over the EVD; and 3) an ICP waveform from a standard-of-care transducer, 4) dimensions (inner diameter and outer diameter) of tunneled catheter. Single patients may be measured multiple times during their admission; each measurement will be considered independent for analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory outcome	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suitability	Number of times the video recording works properly by visually playing back the videos.	1 year

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Rhaeos, Inc.
• Investigators: Principal Investigator: Samuel McClugage, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Hydrocephalus; EVD shunt
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: H-51840

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No