Planning a clinical trial for the Strokefinder MD100 in the Western Cape region

Abstract

Stroke and traumatic brain injury (TBI) represent major causes of mortality and long-term disability globally, with particularly high burden in low- and middle-income countries (LMIC), such as South Africa. The Strokefinder MD100 is a portable device intended for diagnosis and triage of stroke and TBI. This master’s thesis aimed to investigate how clinical trials are conducted within the Western Cape (WC) healthcare system in order to develop a proposal for how, theoretically, a clinical study of the device could be designed and conducted in this context. The study was based on literature studies together with interviews with stakeholders from emergency medicine, neurology, trauma care, prehospital care, academia, and healthcare management in the Western Cape region. The findings suggested that a potential clinical trial could begin with a feasibility and validation study in a tertiary public hospital setting, where device findings are compared to confirmatory CT images as the gold standard, followed by a later phase, investigating possible effects on referral pathways and time-to-treatment within emergency medical services (EMS) and lower level healthcare facilities.