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EVD Drainage Data and Intracranial Pressure (ICP) Measurements - Trial NCT05546996

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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Trial Details
ClinicalTrials.gov โ€ข NCT05546996
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EVD Drainage Data and Intracranial Pressure (ICP) Measurements
The Correlation Between FlowSense Flow Rate Measurements and: EVD Drainage Data and Intracranial Pressure (ICP) Measurements

Study Focus

Hydrocephalus

FlowSense

Interventional

device

Sponsor & Location

Baylor College of Medicine

Timeline & Enrollment

N/A

Jan 01, 2023

Dec 01, 2023

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

Hydrocephalus
Hydrocephalus, unspecified
Other hydrocephalus
Congenital hydrocephalus
Obstructive hydrocephalus

Data Source

ClinicalTrials.gov

NCT05546996

Device Trial