NCT07260916 · Icahn School of Medicine at Mount Sinai
Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation
(MINUTE)
What this study is about
MINUTE is a forward-looking, multi-center, randomly assigned, controlled, blinded assessor, adaptive enrichment design, clinical trial.
View original scientific description
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).
Interventions
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
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.
Primary outcome measures
Utility-Weighted Modified Rankin Scale (UW-mRS)
Time frame: Day 180
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New Brunswick, New Jersey
- New York, New York
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Beth Israel Deaconess Medical Center, Medical University of South Carolina, NINDS Stroke Trials Network (StrokeNet)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations