Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation

Conditions

• Basal Ganglia Intracerebral Hemorrhage

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Endoscopic ICH evacuation — PROCEDURE
  The intervention is minimally invasive endoscopic ICH evacuation using the SCUBA approach29. Stereotactic guidance must be used to guide placement of the sheath into the hematoma. Using stereotactic guidance software, a trajectory is planned along the long axis of the hematoma to the skull while avoiding eloquent brain regions, prominent vasculature, and other anatomy that should not be traversed during the approach, such as the frontal sinuses. A tele-proctor will be available to review the trajectory prior to the procedure starting. The procedure is performed under general anesthesia. The patient's head can be fixed if required depending on the stereotactic navigation system used.
• Standard Medical Treatment — OTHER
  Participating physicians will attest that they will manage all ICH patients in the medical and surgical arms of the trial according to their institutional standards of care, which they will attest are consistent with the American Stroke Association guidelines for management of spontaneous ICH66 and utilize a standardized blood pressure management and hydrocephalus management protocol.

Study Details

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).

Key Dates

Start date

May 15, 2026

Status verified

Mar 2026

Primary completion

Jun 30, 2030

Completion

Jun 30, 2030

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment
  Participants will be treated with SCUBA and Standard Medical Treatment
• Placebo Comparator: Standard Medical Treatment
  Participants will be treated with Standard Medical Treatment

Primary Outcome Measure

Utility-Weighted Modified Rankin Scale (UW-mRS) [ Time Frame: Day 180 ]

Central Contacts

• Ally Qi, MPH
  2093303024
  [email protected]
• Sukaina Davdani
  [email protected]

Locations (1)

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