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Recruiting

NCT Number: NCT05546996

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.

Recruiting

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Key information

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Sarah Martinez, MPH

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with no external ventricular drains (EVDs).

Treatment and study plan

FlowSense

Device

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.

Primary outcomes

  1. Exploratory outcome

    Time frame: 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 outcomes

  1. Suitability

    Time frame: 1 year

    Number of times the video recording works properly by visually playing back the videos.

Study contacts

Contact information is provided by the study sponsor or research team.

Samuel McClugage, MD

CONTACT

[email protected]

8328223950

Sarah Martinez

CONTACT

[email protected]

8328223950

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Rhaeos, Inc.

Registry information

Official study title

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

Acronym: RHAEOS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2022
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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