The clinical trial will be carried out at Satasairaala hospital in Pori, Finland during the next few months
Medicortex seeks to collect a sufficient number of pediatric samples in order to prove the applicability of the brain injury test in children. (Credit: Freeimages/Bebo_agua)
Biotechnology firm Medicortex Finland has commenced the third clinical trial of its diagnostic kit ProbTBI for detection of mild traumatic brain injury (TBI) and concussion in children.
Medicortex is currently developing ProbTBITM that will be used to diagnose brain injury especially in patients who don’t show visible symptoms of brain damage. It is mostly the case with concussion and mild injuries.
The clinical trial will be carried out at Satasairaala hospital in Pori, Finland during the next few months.
Located in Satakunta region, the hospital has first level pediatric emergency department and offers TBI management expertise.
Body fluid samples will be collected from young patients with suspected mild TBI for the trial
For the trial, young patients (0 – 17 years) with suspected mild TBI or concussion following a head injury will be studied with respect to their specific biomarker signature in their bodily fluids.
Medicortex Finland medical director Dr. Mårten Kvist said: “A diagnostic kit for rapid detection of mild TBI in children is truly important. It will satisfy the urgent need to improve the detection of brain injury in children who suffered a head injury.
Through the trial, Medicortex intends to accumulate an adequate number of pediatric samples in order to prove the applicability of the brain injury test in children, as a natural continuation for earlier proven clinical performance in adults.
Medicortex CEO Dr. Adrian Harel said: “ProbTBITM will be a highly innovative diagnostic kit for rapid detection of concussion. Children in particular will benefit from it since they can be refrained from radiation or sedation which are needed for the CT scan of the head, as well as from an exposure to other sick patients in the hospital.
“Participation of the young patients shortly after a head injury will be a challenge, but we have a committed and skilled clinical team working for us in the hospital.”