EVD Drainage Data and Intracranial Pressure (ICP) Measurements
- Disease/Condition
- Hydrocephalus
- Drug/Device/Intervention
- FlowSense
- Study type
- Interventional
- Intervention type
- device
- Primary sponsor
- Baylor College of Medicine
- Phase
- N/A
- Start date
- Jan 01, 2023
- End date
- Dec 01, 2023
- Enrollment
- 24 participants
Exploratory outcome
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT05546996
- Type
- Device Trial
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.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.