Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation (MINUTE)

Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation (MINUTE) Trial

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Basal Ganglia Intracerebral Hemorrhage
• Intervention / Treatment: Procedure: Endoscopic ICH evacuation; Other: Standard Medical Treatment

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sukaina Davdani; Email: sukaina.davdani@mountsinai.org
• Study Contact Backup: Name: Ally Qi, MPH; Phone Number: 2093303024; Email: ally.qi@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Health System
      • Principal Investigator: Christopher Kellner
      • Contact: Emily Svendsen; Phone Number: 212-241-3238; Email: emily.svendsen@mountsinai.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 and ≤ 80 years
• Non-traumatic, spontaneous, supratentorial, non-thalamic, BGH of volume ≥ 20 mL, as determined by the treating physician using ABC/2 method
• NIHSS ≥ 6 at presentation
• Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) is performed and does not show an underlying vascular lesion
• Pre-ICH mRS 0-2 Informed consent from patient or legally authorized representative (LAR) to participate in the trial, wherein patient/LAR's stated wishes are to pursue lifesaving therapies as opposed to early withdrawal of care (explicitly explained as <7 days following ictus)
• The treating physician anticipates that surgery can be initiated <120 min from randomization
• Randomization can occur ≤16 hours from LKW

Exclusion Criteria:

• Suspected secondary cause for the ICH, such as an underlying vascular malformation (cavernous malformation, arteriovenous malformation, etc.), aneurysm, neoplasm, hemorrhagic transformation of an underlying ischemic infarct; or venous infarct Infratentorial or thalamic hemorrhage
• Midbrain extension/involvement
• Coagulopathy defined as international normalized ratio (INR) > 1.4
• Elevated activated Partial Thromboplastin Time (aPTT) > 40 s
• Concurrent use of direct oral anticoagulants or low molecular weight heparin at ICH onset
• Known hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency
• Platelet count <100 x 103 cells/mm3, or known platelet dysfunction (reversal of coagulopathy is not allowed) GCS score <7 at presentation
• Evidence of active infection indicated by fever ≥100.7 °F and/or open draining wound at the time of enrollment
• Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
• Intraventricular extension of the hemorrhage is visually estimated to involve > 50% of either of the lateral ventricles
• Pregnancy (women of childbearing potential must have a negative pregnancy test to participate)
• Based on investigator's judgment, the patient does not have the necessary mental capacity to participate or is unwilling to comply with the protocol follow-up schedule
• Current participation in another interventional (drug or device) trial
• Pre-existing Do Not Resuscitate (DNR)/Do Not Intubate (DNI) status
• History of severe dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment; Participants will be treated with SCUBA and Standard Medical Treatment	Procedure: Endoscopic ICH evacuation; 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.; Other Names: SCUBA; Other: Standard Medical Treatment; 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.
Placebo Comparator: Standard Medical Treatment; Participants will be treated with Standard Medical Treatment	Other: Standard Medical Treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utility-Weighted Modified Rankin Scale (UW-mRS)	Utility-Weighted Modified Rankin Scale (UW-mRS), a tool used primarily in stroke research to measure a patient's disability. It assigns a "utility" value (representing quality of life) to each level of the standard Modified Rankin Scale (mRS) to provide a more nuanced, patient-centered outcome measure than the mRS alone. The utility weighted mRS scales the 0-6 mRS range onto a 0-1 range, with higher scores indicating better health outcomes.	Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of successful endoscopic clot removal	Successful endoscopic clot removal to ≤10 mL remaining clot	during procedure
Volume of clot remaining post endoscopic clot removal	Volume of clot remaining on follow-up 24-hour CT scan post endoscopic clot removal	24 hours post procedure
Number of post-procedural complications adverse events	Symptomatic rebleeding into the cavitary lesion after evacuation resulting in residual hematoma volume >10 mL and worsening of neurological status (defined as an increase in pre-evacuation NIHSS ≥4 points or a decrease in GCS ≥2 points which cannot be attributed to any other cause such as infection, seizures, sedation, or worsening edema) within 30 days.	up to 30 days
Number of CNS infection	CNS infection attributed to surgery	Day 30
Mortality (all-cause)	Number of mortalities, for any reason, at day 30	Day 30

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Medical University of South Carolina; Beth Israel Deaconess Medical Center; National Institute of Neurological Disorders and Stroke (NINDS); NINDS Stroke Trials Network (StrokeNet)
• Investigators: Principal Investigator: Sharon Yeatts, PhD, Medical University of South Carolina; Principal Investigator: J Mocco, MD, Mount Sinai Hospital System; Principal Investigator: Magdy Selim, MD, PhD, Harvard Medical School (HMS and HSDM)

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: November 7, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 3, 2025

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Basal Ganglia; Intracerebral Hemorrhage; SCUBA
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Cerebral Hemorrhage
• Other Study ID Numbers: GCO 23-1905; 1UG3NS138638-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification.
• IPD Sharing Time Frame: Will follow StrokeNet and NIH data sharing guidelines
• IPD Sharing Access Criteria: Submission of (and subsequent approval of) request for use to the appropriate repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No