The second study verifies Strokefinders ability to distinguish between bleeding and clot
Medfields second study, MF02, in order to further verify micro waves ability to distinguish between bleeding and clotting in stroke victims, reinforces the results of the first study. The majority of patients with clot can be separated without wrong diagnosis of patients with bleeding. The study was conducted at the stroke unit at Sahlgrenska University Hospital (SU) in Gothenburg, Sweden.
Medfields first study MF01, that also showed positive results, conducted by Medfields own engineers with a prototype system in which the measurements were made and who had deficiencies in robustness and usability. In MF02 the Strokefinder R10 was used, developed from the results in MF01 and this time no results have been failed because of the system. All patients, 10 with bleeding and 15 with clot, has been treated in the analysis. The format of the MF02 has been closer to the clinical reality since all measurements are made within 24 hours of the first symptoms compared with earlier 48. The operation of Strokefinder R10, which is a more user-friendly system, was made by nurses from stroke unit. The study shows that we can separate 11 of 15 patients with clot without misdiagnose any of the 10 bleeding patients.
“The good results indicate that this may be a medically safe way to select patients with acute stroke symptoms to thrombolytic therapy without prior CT examination,” says Jan-Erik Karlsson, MD, PhD and Senior Consultant in Neurology/Stroke, STROKE SU. “It is also a handy equipment that can be handled by professionals without interfering with the patient’s ordinary treatment. This is of very high hopes that the method can be used for monitoring patients with TIA/ischemic stroke and cerebral hemorrhage for early detection and other medical treatments. This now becomes the main objective of the third study (MF03) which will be carried out in several centers. “
“It’s great that we have continued good results in our second clinical study. Now we have proved that the concept works on two different systems and with upgraded clinical methodology. Patient base is still limited by more than 40 patients so we are at an early stage, but this is of course a shot in the arm that we are working in the right direction. MF03 is in the starting blocks.” Says Patrik Dahlqvist CEO of Medfield Diagnostics AB.
Much of the analysis has been done in collaboration with Chalmers University of Technology. The study also has six first monitoring measurements made on patients while they received thrombolysis. These measurements The primary purpose provided a basis for the product currently underway Stroke Finder M100. M100 series to be used in monitoring of TIA patients in stroke unit that has risk of a full stroke at night.