EVD Drainage Data and Intracranial Pressure (ICP) Measurements

NCT05546996 | Recruiting DMC FDA Device

• 1 other identifier: H-51840
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus

Keywords

EVD shunt; Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Suitability

  1 year

Study Arms (2)

Phase A:

NO INTERVENTION

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

Phase B

OTHER

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

Interventions

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.

Phase B

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients with no external ventricular drains (EVDs).

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Rhaeos, Inc.: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Samuel McClugage, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel McClugage, MD

CONTACT

8328223950; mcclugag@bcm.edu

Sarah Martinez

CONTACT

8328223950; sxwisor@texaschildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor- Neurosurgery

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 21, 2022
• Study Start: July 11, 2023
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)