Recruiting

SCUBA & Management

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07260916

Conditions

Basal Ganglia Intracerebral Hemorrhage

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Endoscopic ICH evacuation

Standard Medical Treatment

Study Details

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).

Conditions

Basal Ganglia Intracerebral Hemorrhage

Study ID

NCT07260916

Start date

Jul 10, 2026

Status verified date

Sep, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Jan 29, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment

Participants will be treated with SCUBA and Standard Medical Treatment

placebo comparator: Standard Medical Treatment

Participants will be treated with Standard Medical Treatment

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.

Primary outcome measure

  • Utility-Weighted Modified Rankin Scale (UW-mRS) [ Time Frame: Day 180 ]
  • Mortality (all-cause) [ Time Frame: Day 30 ]

Central Contacts and Locations

Central contacts

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Principal Investigator:

Michael Alexander, MD

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Paul Vespa, MD

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Principal Investigator:

Charles Matouk, MD

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Sai Priyanka Annadasu

813-844-1053sannadasu@tgh.org

Principal Investigator:

Kunal Vakharia, MD

Lahey Hospital & Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Principal Investigator:

Jonathan Pace, MD

Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Christine Yohn

Cy253@rutgers.edu

Principal Investigator:

Gaurav Gupta, MD

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Caleb Rutledge, MD

The Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Christopher Kellner, MD

NYP Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Contacts

Principal Investigator:

Kurt Yaeger, MD

Baylor Scott & White Medical Center

Recruiting

Temple, Texas, United States, 76508

Contacts

Principal Investigator:

Ethan Benardete, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • Basal Ganglia
  • SCUBA
  • Intracerebral Hemorrhage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-09-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.