Clinical trial underway at five US hospital sites to evaluate Sense’s novel, non-invasive brain scanner to monitor intracranial hemorrhage in acute hospital setting
Drug Controller General of India (DCGI) and Health Canada grant permission to conduct clinical trial at multiple sites in India and Canada
Current standard of care lacks a means to monitor brain injury continuously, non-invasively, in real time, between CT scans
(CINCINNATI, OH – September 27, 2021) Sense Neuro Diagnostics, a medical technology company focused on improving outcomes for stroke and brain injury patients, today announced it has received regulatory clearance from the Drug Controller General of India (DCGI) and Health Canada to expand the pivotal trial of its novel, non-invasive brain scanner to sites in India and Canada. The pivotal trial to evaluate the Sense device to monitor intracranial hemorrhage (ICH) in an acute care setting is underway at multiple trial sites in the US.
The Sense device is a headset equipped with antennae that transmit a low-power tailored radio frequency (RF) pulse across the brain and uses an algorithm to detect signal changes that may indicate an expansion in ICH. The trial follows positive in vitro and in vivo proof of concept studies and a successful first in human feasibility study. It will enroll up to 150 patients in India and Canada (combined) with a diagnostic head CT scan demonstrating primary spontaneous ICH or traumatic ICH within 24 hours of symptom onset or injury. Patients may be actively monitored with the device for up to 48 hours, with results compared with data from regularly scheduled CT scans.
“The international expansion of our pivotal trial will enable us to increase the pool of eligible participants, advancing our effort to assist patients and medical personnel by developing technology to monitor ICH between CT scans and enable earliest detection of changes that may signal an expanding bleed,” said Opeolu Adeoye, MD, MS, Chief Medical Officer of Sense Diagnostics and Medical Director of the clinical trial.
Stroke is the second leading cause of death and a major cause of disability worldwide.
Ongoing or repeat bleeding in the brain, experienced by about 40% of patients following a hemorrhagic stroke, contributes to decreased brain function and poor outcomes. Repeat bleeding may be difficult to detect under the current standard of care, which is for a nurse or physician to assess the patient every one to eight hours by having the patient respond to a series of questions and commands.
Sense has contracted with investigators at four trial sites in India, including All India Institute of Medical Sciences (AIIMS) in Delhi, with activity expected to begin in early Q4 2021.
“The expansion of our pivotal trial into India provides a platform to develop our strategy to improve healthcare through innovation in developing and low/middle income countries,” said Sense Neuro Diagnostics CEO Geoffrey Klass.
Contracts with clinical trial sites in Canada are being finalized.