Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation
MINUTE
2 other identifiers
interventional
300
1 country
44
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2025
CompletedFirst Posted
Study publicly available on registry
December 3, 2025
CompletedStudy Start
First participant enrolled
July 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2030
September 15, 2026
September 1, 2026
2.6 years
November 7, 2025
September 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Mortality (all-cause)
Number of mortalities, for any reason, at day 30
Day 30
Secondary Outcomes (5)
Number of successful endoscopic clot removal
during procedure
Volume of clot remaining post endoscopic clot removal
24 hours post procedure
Number of post-procedural complications adverse events
up to 30 days
Number of CNS infection
Day 30
Peri-cavity edema (PCE)
24 hour
Study Arms (2)
Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment
EXPERIMENTALParticipants will be treated with SCUBA and Standard Medical Treatment
Standard Medical Treatment
PLACEBO COMPARATORParticipants will be treated with Standard Medical Treatment
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- CTA or MRA is performed and does not show an underlying vascular lesion
- Pre-ICH mRS 0-2
- 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)
- The treating physician anticipates that surgery can be initiated \<120 min from randomization
- Randomization within 16 hours from LKW and within 2 hours of arrival to the randomizing center.
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Banner University Medical Center - Phoenix
Phoenix, Arizona, 85006, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
Banner University Medical Center - Tucson Campus
Tucson, Arizona, 85719, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
John Muir Medical Center - Walnut Creek Campus
Walnut Creek, California, 94598, United States
Yale New Haven Hospital
New Haven, Connecticut, 06519, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Illinois Hospital
Chicago, Illinois, 60612, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
University of Missouri Health Care
Columbia, Missouri, 65212, United States
SSM Health St. Louis University Hospital
St Louis, Missouri, 63104, United States
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
JFK Medical Center
Edison, New Jersey, 08820, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
Buffalo General Medical Center
Buffalo, New York, 14203, United States
NYU Langone Health
New York, New York, 10016, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
NYP Weill Cornell Medical Center
New York, New York, 10065, United States
Oregon Health & Science University Hospital
Portland, Oregon, 97239, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, 57105, United States
Vanderbilt University Hospital
Nashville, Tennessee, 37232, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030, United States
Baylor Scott & White Medical Center
Temple, Texas, 76508, United States
University of Utah Healthcare
Salt Lake City, Utah, 84132, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
J.W. Ruby Memorial Hospital
Morgantown, West Virginia, 26506, United States
University of Wisconsin University Hospital
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J Mocco, MD, MS
Weill Medical College of Cornell University
- PRINCIPAL INVESTIGATOR
Magdy Selim, MD, PhD
Beth Israel Deaconess Medical Center
- PRINCIPAL INVESTIGATOR
Sharon Yeatts, PhD
Medical University of South Carolina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- MINUTE is an on-label study with a blinded end-point outcome assessment, i.e. participants, providers, and site investigators will not be blinded to treatment assignments. Blinding is difficult, if not impossible, from a clinical perspective. It is not possible to blind the Investigator who treats the patient, the clinical staff, or the research team. Physicians treating participants who experience an AE after must know how the hemorrhage was treated in order to effectively report the AE and plan further treatment. However, MINUTE will require that study-related follow-up assessments be conducted by blinded investigators certified in mRS assessment, who were not involved in clinical care of the participant and are unaware of the patient's randomization status. A large Band-Aid will be placed on every patient's forehead prior to blinded assessor review, thereby preventing scar visualization or misinterpretation of unrelated scars on control patients.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2025
First Posted
December 3, 2025
Study Start
July 10, 2026
Primary Completion (Estimated)
January 29, 2029
Study Completion (Estimated)
July 31, 2030
Last Updated
September 15, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Will follow StrokeNet and NIH data sharing guidelines
- Access Criteria
- Submission of (and subsequent approval of) request for use to the appropriate repository.
Individual participant data that underlie the results reported in this article, after deidentification.