NCT05546996

EVD Drainage Data and Intracranial Pressure (ICP) Measurements

The Correlation Between FlowSense Flow Rate Measurements and: EVD Drainage Data and Intracranial Pressure (ICP) Measurements
Baylor College of Medicine·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Hydrocephalus
Drug/Device/Intervention
FlowSense
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Baylor College of Medicine
Timeline & enrollment
Phase
N/A
Start date
Jan 01, 2023
End date
Dec 01, 2023
Enrollment
24 participants
Primary outcome

Exploratory outcome

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.

ICD-10 classifications
HydrocephalusHydrocephalus, unspecifiedOther hydrocephalusCongenital hydrocephalusObstructive hydrocephalus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05546996
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05546996 through Pure Global AI's free database. This phase not specified trial is sponsored by Baylor College of Medicine and is currently Not yet recruiting. The study focuses on Hydrocephalus. Target enrollment is 24 participants.

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