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

September 10, 2026 updated by: Weill Medical College of Cornell University

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Not yet recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Benard Bendok, MD
      • Phoenix, Arizona, United States, 85006
        • Not yet recruiting
        • Banner University Medical Center - Phoenix
        • Contact:
        • Principal Investigator:
          • Daniel Cavalcanti, MD
      • Tucson, Arizona, United States, 85719
        • Not yet recruiting
        • Banner University Medical Center - Tucson Campus
        • Contact:
        • Principal Investigator:
          • Michael Avery, MD
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Michael Alexander, MD
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Ronald Reagan UCLA Medical Center
        • Contact:
        • Principal Investigator:
          • Paul Vespa, MD
      • Los Angeles, California, United States, 90033
        • Not yet recruiting
        • Keck Hospital of USC
        • Contact:
        • Principal Investigator:
          • May Kim-Tenser, MD
      • Sacramento, California, United States, 95817
        • Not yet recruiting
        • UC Davis Medical Center
        • Contact:
        • Principal Investigator:
          • Ben Waldau, MD
      • Walnut Creek, California, United States, 94598
        • Not yet recruiting
        • John Muir Medical Center - Walnut Creek Campus
        • Contact:
        • Principal Investigator:
          • Benjamin Yim, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale New Haven Hospital
        • Principal Investigator:
          • Charles Matouk, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • Jackson Memorial Hospital
        • Principal Investigator:
          • Robert Starke, MD
        • Contact:
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Principal Investigator:
          • Kunal Vakharia, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Northwestern Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Babak Jahromi, MD
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • University of Illinois Hospital
        • Contact:
        • Principal Investigator:
          • Francesco Pucci, MD
      • Park Ridge, Illinois, United States, 60068
        • Not yet recruiting
        • Advocate Lutheran General Hospital
        • Principal Investigator:
          • Krishna Joshi, MD
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Not yet recruiting
        • University of Louisville Hospital
        • Contact:
        • Principal Investigator:
          • Redi Rahmani, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Christopher Ogilvy, MD
        • Contact:
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Hospital & Medical Center
        • Contact:
        • Principal Investigator:
          • Jonathan Pace, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Not yet recruiting
        • University of Mississippi Medical Center
        • Contact:
        • Principal Investigator:
          • Allison Strickland, MD
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Not yet recruiting
        • University of Missouri Health Care
        • Principal Investigator:
          • Michael Chicoine, MD
        • Contact:
      • St Louis, Missouri, United States, 63104
        • Not yet recruiting
        • SSM Health St. Louis University Hospital
        • Contact:
        • Principal Investigator:
          • Diana Greene-Chandos, MD
      • St Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Washington University - Barnes Jewish Hospital
        • Contact:
        • Principal Investigator:
          • Raj Dhar, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Not yet recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Mithun Sattur, MD
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Not yet recruiting
        • Cooper University Hospital
        • Principal Investigator:
          • Daniel Tonetti, MD
        • Contact:
      • Edison, New Jersey, United States, 08820
        • Not yet recruiting
        • JFK Medical Center
        • Principal Investigator:
          • Brian Jankowitz, MD
        • Contact:
      • Neptune City, New Jersey, United States, 07753
        • Not yet recruiting
        • Jersey Shore University Medical Center
        • Principal Investigator:
          • Paul Singh, MD
        • Contact:
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Robert Wood Johnson University Hospital
        • Principal Investigator:
          • Gaurav Gupta, MD
        • Contact:
      • Summit, New Jersey, United States, 07901
    • New York
      • Buffalo, New York, United States, 14203
        • Not yet recruiting
        • Buffalo General Medical Center
        • Contact:
        • Principal Investigator:
          • Jason Davies, MD
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
        • Principal Investigator:
          • Caleb Rutledge, MD
      • New York, New York, United States, 10029
        • Recruiting
        • The Mount Sinai Hospital
        • Principal Investigator:
          • Christopher Kellner, MD
        • Contact:
      • New York, New York, United States, 10065
        • Recruiting
        • NYP Weill Cornell Medical Center
        • Contact:
        • Principal Investigator:
          • Kurt Yaeger, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Oregon Health & Science University Hospital
        • Principal Investigator:
          • Jesse Liu, MD
        • Contact:
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Not yet recruiting
        • Geisinger Medical Center
        • Principal Investigator:
          • Clemens Schirmer, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Not yet recruiting
        • Avera McKennan Hospital & University Health Center
        • Contact:
        • Principal Investigator:
          • Randy Bell, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Vanderbilt University Hospital
        • Contact:
        • Principal Investigator:
          • Rohan Chitale, MD
    • Texas
      • Galveston, Texas, United States, 77555
        • Not yet recruiting
        • University of Texas Medical Branch
        • Principal Investigator:
          • Peter Kan, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Houston Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Alex Hoang, MD
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Memorial Hermann Texas Medical Center
        • Contact:
        • Principal Investigator:
          • Ritvij Bowry, MD
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White Medical Center
        • Contact:
        • Principal Investigator:
          • Ethan Benardete, MD
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Not yet recruiting
        • University of Utah Healthcare
        • Principal Investigator:
          • Ramesh Grandhi, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98104
        • Not yet recruiting
        • Harborview Medical Center
        • Principal Investigator:
          • David Tirschwell, MD
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Not yet recruiting
        • J.W. Ruby Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Ryan Turner, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Not yet recruiting
        • University of Wisconsin University Hospital
        • Contact:
        • Principal Investigator:
          • Azam Ahmed, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
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.
Day 180
Mortality (all-cause)
Time Frame: Day 30
Number of mortalities, for any reason, at day 30
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of successful endoscopic clot removal
Time Frame: during procedure
Successful endoscopic clot removal to ≤10 mL remaining clot
during procedure
Volume of clot remaining post endoscopic clot removal
Time Frame: 24 hours post procedure
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
Time Frame: up to 30 days
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
Time Frame: Day 30
CNS infection attributed to surgery
Day 30
Peri-cavity edema (PCE)
Time Frame: 24 hour
PCE on the 24-hour CT scan
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

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: Magdy Selim, MD, PhD, Beth Israel Deaconess Medical Center
  • Principal Investigator: J Mocco, MD, MS, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2026

Primary Completion (Estimated)

January 29, 2029

Study Completion (Estimated)

July 31, 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)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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