This study is a two-stage, pivotal, prospective, non-randomized, multi-center, within patient comparison of the SENSE device and the standard diagnostic test, head CT scan in patients with a diagnosis of primary spontaneous ICH (parenchymal ICH without secondary causes, such as arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation of ischemic stroke, venous sinus thrombosis) or traumatic intracranial bleeding (defined as epidural hemorrhage, subdural hemorrhage and/or traumatic contusions/intraparenchymal hemorrhage) for the detection and monitoring of intracranial hemorrhages. All subjects with any spontaneous or traumatic ICH who meet eligibility criteria should be enrolled. We anticipate that some TBI patients with traumatic ICH may not have a prolonged hospital stay and the standard practice in these patients who do not experience hemorrhage expansion is to obtain a head CT within 6-24 hours. It is anticipated that the majority of subjects admitted to the hospital, i.e., spontaneous ICH or TBI patients who experience hemorrhage expansion, will be managed in an intensive care unit (ICU). Mild TBI with traumatic ICH patients may be managed outside of an ICU depending on local practice. The SENSE device will be evaluated in subjects at risk of early and delayed hemorrhage expansion.
This study is a two-stage, pivotal, prospective, non-randomized, multi-center, within patient comparison of the SENSE device and the standard diagnostic test, head CT scan in patients with a diagnosis of primary spontaneous ICH or traumatic intracranial bleeding for the detection and monitoring of intracranial hemorrhages.