Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation

NCT07260916 | Not Yet Recruiting DMC

• 2 other identifiers: GCO 23-19051UG3NS138638-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

Basal Ganglia; SCUBA; Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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

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

• Mortality (all-cause)

  Day 30

Study Arms (2)

Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment

EXPERIMENTAL

Participants will be treated with SCUBA and Standard Medical Treatment

Procedure: Endoscopic ICH evacuation; Other: Standard Medical Treatment

Standard Medical Treatment

PLACEBO COMPARATOR

Participants will be treated with Standard Medical Treatment

Other: Standard Medical Treatment

Interventions

Endoscopic ICH evacuation PROCEDURE

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.

Also known as: SCUBA

Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment

Standard Medical Treatment OTHER

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.

Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment; Standard Medical Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

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
• Pre-existing Do Not Resuscitate (DNR)/Do Not Intubate (DNI) status
• History of severe dementia

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Medical University of South Carolina: collaborator
• NINDS Stroke Trials Network (StrokeNet): collaborator

Study Sites (1)

Mount Sinai Health System

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• J Mocco, MD

  Mount Sinai Hospital System

  PRINCIPAL INVESTIGATOR

• Magdy Selim, MD, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

• Sharon Yeatts, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ally Qi, MPH

CONTACT

2093303024; ally.qi@mountsinai.org

Sukaina Davdani

CONTACT

sukaina.davdani@mountsinai.org

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: PRINCIPAL INVESTIGATOR
• PI Title: National Principal Investigator

Model Details: Adult patients (18-80 years old) with spontaneous Basal Ganglia (BG) intracerebral hemorrhage (ICH) ≥20 mL able to be randomized for endoscopic evacuation within 16 hours of ICH onset or last known well (LKW). Endoscopic minimally invasive Stereotactic Cerebral Underwater Blood Aspiration (SCUBA) of spontaneous basal ganglia ICH (BGH)

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: December 3, 2025
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: March 10, 2026

Record last verified: 2026-03

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.

Locations

US (1)