NCT07260916 Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation
| NCT ID | NCT07260916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Basal Ganglia Intracerebral Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-07-15 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2026-07-15 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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
Contact & Investigator
J Mocco, MD
PRINCIPAL INVESTIGATOR
Mount Sinai Hospital System
Frequently Asked Questions
Who can join the NCT07260916 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Basal Ganglia Intracerebral Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07260916 currently recruiting?
Yes, NCT07260916 is actively recruiting participants. Contact the research team at ally.qi@mountsinai.org for enrollment information.
Where is the NCT07260916 trial being conducted?
This trial is being conducted at New Brunswick, United States, New York, United States.
Who is sponsoring the NCT07260916 clinical trial?
NCT07260916 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is J Mocco, MD at Mount Sinai Hospital System. The trial plans to enroll 300 participants.