During the feasibility study six activity streams were carried out: (1) Detailed analysis of clinical needs/benefits based on a literature review and a survey with a structured questionnaire, (2) development of a health economics model, (3) e-ASPECTSTW technical specifications, (4) design of the protocol study and operational structure for phase 2 study, (5) risk analysis which included the identification of risks and mitigation actions related to the study, the technology and the commercialisation issues, and (6) a full business plan with market and competition analysis, positioning, marketing and market entry strategy and financial projections.
The result of the feasibility study is that the TISSUE trial will be a drug trial (with the thrombolytic drug rt-PA), as the medical device e-ASPECTSTW will be an augmented version of e-ASPECTS which is already CE marked. The trial will only include patients with symptoms of stroke on awakening (wake-up patients). The planned participating sites will be in UK, Greece and Poland. The protocol for this study has been designed in detail and the operational resource allocation has been arranged between Brainomix, George Clinical and FGK Clinical Research GmbH. In addition, a steering committee of stroke experts has been formed with a view towards the implementation of the study. 30 hospitals in UK, Greece and Poland have expressed interest to participate in the TISSUE study. The total cost of the phase II project will be 4,995,226 Euros and will last 3.5 years.
