Minimally invasive surgery for intracerebral hemorrhage

This document outlines the protocol for a multicenter, randomized clinical study evaluating the effectiveness and safety of minimally invasive surgery (MIS) using the Artemis Neuro Evacuation Device for treating supratentorial intracerebral hemorrhage (ICH) compared to conventional medical management (MM). The study employs an adaptive design with potential interim analyses to assess efficacy and possibly stop early for success or futility. It details the responsibilities of the sponsor and investigators, emphasizing ethical considerations like informed consent and subject data protection. Various neurological exams and stroke scales are used for assessment, and the document also covers risk analysis, adverse event reporting, and statistical procedures for analyzing outcomes, including 30-day mortality as a primary safety endpoint and 180-day global disability as a primary efficacy endpoint.