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EVD Drainage Data and Intracranial Pressure (ICP) Measurements

NCT05546996 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Rhaeos, Inc.

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Samuel McClugage, MD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2027-01-30
Completion
2027-01-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05546996 on ClinicalTrials.gov