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Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation
Sponsor: Weill Medical College of Cornell University
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).
Official title: Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation (MINUTE) Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-07-10
Completion Date
2030-07-31
Last Updated
2026-09-15
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (44)
Banner University Medical Center - Phoenix
Phoenix, Arizona, United States
Mayo Clinic
Phoenix, Arizona, United States
Banner University Medical Center - Tucson Campus
Tucson, Arizona, United States
Keck Hospital of USC
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
John Muir Medical Center - Walnut Creek Campus
Walnut Creek, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Jackson Memorial Hospital
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Illinois Hospital
Chicago, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Missouri Health Care
Columbia, Missouri, United States
SSM Health St. Louis University Hospital
St Louis, Missouri, United States
Washington University - Barnes Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Cooper University Hospital
Camden, New Jersey, United States
JFK Medical Center
Edison, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Overlook Medical Center
Summit, New Jersey, United States
Buffalo General Medical Center
Buffalo, New York, United States
NYU Langone Health
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
NYP Weill Cornell Medical Center
New York, New York, United States
Oregon Health & Science University Hospital
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, United States
Vanderbilt University Hospital
Nashville, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
Baylor Scott & White Medical Center
Temple, Texas, United States
University of Utah Healthcare
Salt Lake City, Utah, United States
Harborview Medical Center
Seattle, Washington, United States
J.W. Ruby Memorial Hospital
Morgantown, West Virginia, United States
University of Wisconsin University Hospital
Madison, Wisconsin, United States