The Southeast Regional Stroke Center at Erlanger enrolled the world’s first patient in a new clinical study for early detection of traumatic brain injury and stroke.
EXPEDITE (Evaluate a NeXt Generation PortablE Diagnostic Platform for Determination and Immediate Triage of Emergency Large Vessel Stroke) is a three phase clinical study program to evaluate Neural Analytics’ portable monitoring platform for patients suffering an acute ischemic stroke. The technology uses ultrasound to measure blood flow in the patient’s brain and may give clinicians important information to more rapidly assist in the diagnoses and monitoring of stroke patients.
“The development of a more convenient, quantitative assessment system for early detection of stroke is one of our most critical needs,” said Dr.
Tom Devlin, medical director of Erlanger’s Southeast Regional Stroke Center and principal investigator of the study. “We believe such a diagnostic tool will transform global patient care when it becomes available. We are thrilled to be the first site in the world to evaluate this technology.”
The study will enroll 150 patients who are suspected of having a Large Vessel Occlusion (LVO) Stroke and determine if Neural Analytics’ technology can assist clinicians in quickly assessing stroke risk in the Emergency Room setting. Study results are projected to be available in 2017.
“We are pleased to enroll our first patient in the EXPEDITE study which will help us develop clinical evidence to demonstrate that our next-generation ultrasound technology can help clinicians.” said Leo Petrossian, chief executive officer of Neural Analytics. "We plan to use the data to support the company’s multiple global regulatory submissions as well as commercialization in 2017.”
Neural Analytics’ technology is currently under FDA and CE mark review for the monitoring of blood flow in the cerebral vasculature. It is not available for commercial use or sale.