Table 1.

Three stages of investigational research for the novel dural repair device.

Part A: Clinical simulation	Part B: Clinical simulation	Part C: Operating room
Ten participants comparing novel dural repair device & traditional suture techniques	Ten participants comparing novel dural repair device & traditional suture techniques	The authors evaluated their clinical experiences using the novel device intraoperatively against the benchtop results
Primary endpoints: time to gain control of the tear by bringing the center of defect edges together using the initial suture	Primary endpoints: time to complete the total repair with two sutures, quality of repair and neurological safety (entrapped nerve roots)	Qualitative assessment of the realization of the experience captured in the simulated environment