The Correlation Between FlowSense Flow Rate Measurements And: EVD Drainage Data and Intracranial Pressure (ICP) Measurements

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 21
Healthy Volunteers: f
View:

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

Locations
United States
Texas
Texas Children's Hospital
RECRUITING
Houston
Contact Information
Primary
Samuel McClugage, MD
mcclugag@bcm.edu
8328223950
Backup
Sarah Martinez
sxwisor@texaschildrens.org
8328223950
Time Frame
Start Date: 2023-07-11
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 24
Treatments
No_intervention: Phase A:
Establish suitability of digital video recording system for quantifying CSF drainage into an EVD drainage system.
Other: Phase B
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
Related Therapeutic Areas
Sponsors
Collaborators: Rhaeos, Inc.
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov