Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation

MINUTE is a prospective, multi-center, randomized, controlled, blinded assessor, adaptive enrichment design, clinical trial. Eligible patients with spontaneous BGH ≥20 mL will be randomized 1:1 to either minimally invasive endoscopic SCUBA evacuation plus standard medical management or standard medical management alone; the time of randomization will be used to classify participants in one of two cohorts: 1) those randomized \<8 hours from onset, and 2) those randomized 8-16 hours from onset. Randomization is targeted to occur within 120 min of arrival to the randomizing center's Emergency Department (ED), and initiation of surgery is targeted to occur within 120 min of randomization. Participants will be followed at 30, 90, 180, and 365 days to assess for adverse events (AEs) and utility-weighted modified Rankin Scale (UW-mRS).

NCT Number	NCT07260916
Lead Sponsor	Icahn School of Medicine at Mount Sinai Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Beth Israel Deaconess Medical Center, Medical University of South Carolina, NINDS Stroke Trials Network (StrokeNet)
Conditions	Basal Ganglia Intracerebral Hemorrhage
Enrollment	300 participants
Start Date	2026-07-15
Primary Completion	2030-06-30 (estimated)
Study Completion	2030-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-29