Table 3 Safety and feasibility metrics assessed across the procedures
Outcome | Test | Assessment timepoint | Assessment method |
|---|---|---|---|
Safety | Macroscopic examination assessing: • Tissue deformation • Hemorrhage • Tearing of brain tissue | Post-explantation, end of procedure | Presence or absence based on necropsy of ovine brain. |
Safety | Incidence of intra-operative adverse events. | Throughout procedure | Intraoperative anesthetic monitoring and evaluation of surgical field. |
Feasibility | Ability to navigate to site of interest and manipulate different tissues including: • Arachnoid • Nerves • Blood vessels | Throughout procedure | Assessing the ability to manipulate tissues via the following scoring: 1 = very easy 2 = easy 3 = hard 4 = very hard |
