US-based medical device company Neural Analytics has enrolled its first patient in the Evaluate a NeXt Generation PortablE Diagnostic Platform for Determination and Immediate Triage of Emergency Large Vessel Stroke (EXPEDITE) Phase 1 trial at Erlanger Health System in Chattanooga, Tennessee.
EXPEDITE will evaluate the company’s portable monitoring platform for patients suffering an acute ischemic stroke.
The study will asses the Neural Analytics’ technology to evaluate patients for stroke and if rapid early evaluation in the emergency room can quicken treatment and improve patient outcomes.
Erlanger Health System Southeast Regional Stroke Center medical director and principal investigator of the study Tom Devlin said: “The creation of a convenient, quantitative assessment system for the early detection of stroke is one of our most critical needs.
"We believe such a diagnostic tool will transform global patient management when it becomes available.
“We are thrilled to be the first site in the world to begin evaluation of this promising technology, which uses ultrasound to rapidly assess blood flow in the brain and may help healthcare professionals determine if a patient is suffering a stroke.”
The study will be conducted to assess the Neural Analytics technology's ability to assist clinicians in more rapidly examining stroke risk in the emergency room setting in 150 patients, who are suspected of having a Large Vessel Occlusion (LVO) Stroke.
Neural Analytics chief executive officer Leo Petrossian said: “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 rapidly assess and monitor stroke patients.
"We plan to use the data to support the company’s multiple global regulatory submissions as well as commercialisation in 2017.”
The technology is under US Food and Drug Administration and CE mark review for monitoring blood flow in cerebral vasculature.