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Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation

Recruiting

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

Who can join

Ages 18 to 80 · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years
2. Non-traumatic, spontaneous, supratentorial, non-thalamic, BGH of volume ≥ 20 mL, as determined by the treating physician using ABC/2 method
3. NIHSS ≥ 6 at presentation
4. CTA or MRA is performed and does not show an underlying vascular lesion
5. Pre-ICH mRS 0-2
6. Informed consent from patient or 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)
7. The treating physician anticipates that surgery can be initiated \<120 min from randomization
8. Randomization within 16 hours from LKW and within 2 hours of arrival to the randomizing center.

Exclusion Criteria:

1. 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
2. Infratentorial or thalamic hemorrhage
3. Midbrain extension/involvement
4. Coagulopathy defined as international normalized ratio (INR) \> 1.4
5. Elevated activated Partial Thromboplastin Time (aPTT) \> 40 s
6. Concurrent use of direct oral anticoagulants or low molecular weight heparin at ICH onset
7. Known hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency
8. Platelet count \<100 x 103 cells/mm3, or known platelet dysfunction (reversal of coagulopathy is not allowed)
9. GCS score \<7 at presentation
10. Evidence of active infection indicated by fever ≥100.7 °F and/or open draining wound at the time of enrollment
11. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
12. Intraventricular extension of the hemorrhage is visually estimated to involve \> 50% of either of the lateral ventricles
13. Pregnancy (women of childbearing potential must have a negative pregnancy test to participate)
14. 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
15. Current participation in another interventional (drug or device) trial
16. Pre-existing Do Not Resuscitate (DNR)/Do Not Intubate (DNI) status
17. History of severe dementia

About the study

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).

What is being tested

Sponsor: Weill Medical College of Cornell University · Participants: 300 · Started: Jul 10, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07260916

Locations in the U.S.

ArizonaBanner University Medical Center - Phoenix, Phoenix (Not yet recruiting)
Mayo Clinic, Phoenix (Not yet recruiting)
Banner University Medical Center - Tucson Campus, Tucson (Not yet recruiting)
CaliforniaCedars-Sinai Medical Center, Los Angeles
Keck Hospital of USC, Los Angeles (Not yet recruiting)
Ronald Reagan UCLA Medical Center, Los Angeles
UC Davis Medical Center, Sacramento (Not yet recruiting)
John Muir Medical Center - Walnut Creek Campus, Walnut Creek (Not yet recruiting)
ConnecticutYale New Haven Hospital, New Haven
FloridaJackson Memorial Hospital, Miami (Not yet recruiting)
Tampa General Hospital, Tampa
IllinoisNorthwestern Memorial Hospital, Chicago (Not yet recruiting)
University of Illinois Hospital, Chicago (Not yet recruiting)
Advocate Lutheran General Hospital, Park Ridge (Not yet recruiting)
KentuckyUniversity of Louisville Hospital, Louisville (Not yet recruiting)
MassachusettsBeth Israel Deaconess Medical Center, Boston (Not yet recruiting)
Lahey Hospital & Medical Center, Burlington
MississippiUniversity of Mississippi Medical Center, Jackson (Not yet recruiting)
MissouriUniversity of Missouri Health Care, Columbia (Not yet recruiting)
SSM Health St. Louis University Hospital, St Louis (Not yet recruiting)
Washington University - Barnes Jewish Hospital, St Louis (Not yet recruiting)
NebraskaUniversity of Nebraska Medical Center, Omaha (Not yet recruiting)
New JerseyCooper University Hospital, Camden (Not yet recruiting)
JFK Medical Center, Edison (Not yet recruiting)
Jersey Shore University Medical Center, Neptune City (Not yet recruiting)
Robert Wood Johnson University Hospital, New Brunswick
Overlook Medical Center, Summit (Not yet recruiting)
New YorkBuffalo General Medical Center, Buffalo (Not yet recruiting)
NYP Weill Cornell Medical Center, New York
NYU Langone Health, New York
The Mount Sinai Hospital, New York
OregonOregon Health & Science University Hospital, Portland (Not yet recruiting)
PennsylvaniaGeisinger Medical Center, Danville (Not yet recruiting)
Hospital of the University of Pennsylvania, Philadelphia (Not yet recruiting)
South DakotaAvera McKennan Hospital & University Health Center, Sioux Falls (Not yet recruiting)
TennesseeVanderbilt University Hospital, Nashville (Not yet recruiting)
TexasUniversity of Texas Medical Branch, Galveston (Not yet recruiting)
Houston Methodist Hospital, Houston (Not yet recruiting)
Memorial Hermann Texas Medical Center, Houston (Not yet recruiting)
Baylor Scott & White Medical Center, Temple
UtahUniversity of Utah Healthcare, Salt Lake City (Not yet recruiting)
WashingtonHarborview Medical Center, Seattle (Not yet recruiting)
West VirginiaJ.W. Ruby Memorial Hospital, Morgantown (Not yet recruiting)
WisconsinUniversity of Wisconsin University Hospital, Madison (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.