Recruiting

SCUBA & Management

Sponsor:

Icahn School of Medicine at Mount Sinai

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 15, 2026

Status verified date

Jun, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) is performed and does not show an underlying vascular lesion
  • Pre-ICH mRS 0-2 Informed consent from patient or legally authorized representative (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 can occur ≤16 hours from LKW

Exclusion Criteria:

  • 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
  • Pre-existing Do Not Resuscitate (DNR)/Do Not Intubate (DNI) status
  • 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 ]

Central Contacts and Locations

Central contacts

Ally Qi, MPH

2093303024ally.qi@mountsinai.org

Sukaina Davdani

sukaina.davdani@mountsinai.org

Locations

Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator:

Gaurav Gupta, MD

Mount Sinai Health System

Recruiting

New York, New York, United States, 10029

Contacts

Emily Svendsen

212-241-3238emily.svendsen@mountsinai.org

Principal Investigator:

Christopher Kellner

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Basal Ganglia
  • SCUBA
  • Intracerebral Hemorrhage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-29.