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Basal Ganglia Intracerebral HemorrhageMINUTENCT07260916

Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation

A study testing Endoscopic ICH evacuation and Standard Medical Treatment in people with Basal Ganglia Intracerebral Hemorrhage, run by Weill Medical College of Cornell University at 44 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Basal Ganglia Intracerebral Hemorrhage
What is being tested?
Endoscopic ICH evacuation and Standard Medical Treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
44 sitesUnited States
Study dates
10 Jul 2026to 31 Jul 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • CTA or MRA is performed and does not show an underlying vascular lesion
  • Pre-ICH mRS 0-2
  • 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)
  • The treating physician anticipates that surgery can be initiated <120 min from randomization
  • Randomization within 16 hours from LKW and within 2 hours of arrival to the randomizing center.

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

44 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ally Qi, MPH contact

209-330-3024

alq4003@med.cornell.edu

Cynthia Nguyen, MsCR contact

cyn4002@med.cornell.edu

44 sites in 1 country

United States44 sites, 44 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Mark Rotondo, mrotondo@bidmc.harvard.edu

    Christopher Ogilvy, MD

    Not yet recruiting

  • Buffalo General Medical Center

    Buffalo, New York, 14203

    Michaela Laskowski, mlaskowski@ubns.com

    Jason Davies, MD

    Not yet recruiting

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

    Madison Liesching, Madison.Liesching@lahey.org

    Jonathan Pace, MD

    Recruiting

  • Cooper University Hospital

    Camden, New Jersey, 08103

    Thuy Van Cao, cao-thuy@CooperHealth.edu

    Daniel Tonetti, MD

    Not yet recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Ashkan Zarrieneh, Ashkan.Zarrieneh@nm.org

    Babak Jahromi, MD

    Not yet recruiting

  • University of Illinois Hospital

    Chicago, Illinois, 60612

    Luzy Rosales, luzr@uic.edu

    Francesco Pucci, MD

    Not yet recruiting

  • University of Missouri Health Care

    Columbia, Missouri, 65212

    Brooke Hoffman, hoffmanba@missouri.edu

    Michael Chicoine, MD

    Not yet recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Chelsie Derr, cmderr1@geisinger.edu

    Clemens Schirmer, MD

    Not yet recruiting

  • JFK Medical Center

    Edison, New Jersey, 08820

    Alexandra Burbelo, alexandra.burbelo@hmhn.org

    Brian Jankowitz, MD

    Not yet recruiting

  • University of Texas Medical Branch

    Galveston, Texas, 77555

    Jennifer Cornwell, jacornwe@utmb.edu

    Peter Kan, MD

    Not yet recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Amber Behne, abehne@houstonmethodist.org

    Alex Hoang, MD

    Not yet recruiting

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

    Atzhiry Paz, Atzhiry.S.Paz@uth.tmc.edu

    Ritvij Bowry, MD

    Not yet recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Thomas Hudson, tmhudson@umc.edu

    Allison Strickland, MD

    Not yet recruiting

  • Keck Hospital of USC

    Los Angeles, California, 90033

    Clare Binley, clare.binley@med.usc.edu

    May Kim-Tenser, MD

    Not yet recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Sun Ming Na, SungMin.Na@cshs.org

    Michael Alexander, MD

    Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

    Chevelle Sleaford, 310-948-0491, CSleaford@mednet.ucla.edu

    Paul Vespa, MD

    Recruiting

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

    Ann Jerde, aljerd01@louisville.edu

    Redi Rahmani, MD

    Not yet recruiting

  • University of Wisconsin University Hospital

    Madison, Wisconsin, 53792

    Sima Sayyahmelli, sayyahmelli@neurosurgery.wisc.edu

    Azam Ahmed, MD

    Not yet recruiting

  • Jackson Memorial Hospital

    Miami, Florida, 33136

    Jayro Toledo, j.toledo2@med.miami.edu

    Robert Starke, MD

    Not yet recruiting

  • J.W. Ruby Memorial Hospital

    Morgantown, West Virginia, 26506

    Jay Sherman, shermanj@wvumedicine.org

    Ryan Turner, MD

    Not yet recruiting

  • Vanderbilt University Hospital

    Nashville, Tennessee, 37232

    Anna Bican, anna.bican@vumc.org

    Rohan Chitale, MD

    Not yet recruiting

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

    Abimbola Coker, abimbola.coker@hmhn.org

    Paul Singh, MD

    Not yet recruiting

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901

    Christine Yohn, Cy253@rutgers.edu

    Gaurav Gupta, MD

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06519

    Kristin DeFrancesco, 203-915-7609, kristin.defrancesco@yale.edu

    Charles Matouk, MD

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Michelle Sclafani, 646-501-0368, Michelle.Sclafani@nyulangone.org

    Caleb Rutledge, MD

    Recruiting

  • The Mount Sinai Hospital

    New York, New York, 10029

    Emily Svendsen, 212-241-3238, emily.svendsen@mountsinai.org

    Christopher Kellner, MD

    Recruiting

  • NYP Weill Cornell Medical Center

    New York, New York, 10065

    Jackson Hagen, jrh4002@med.cornell.edu

    Kurt Yaeger, MD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Jill Skorupa, jilskorupa@unmc.edu

    Mithun Sattur, MD

    Not yet recruiting

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

    Miharsh Patel, Miharsh.Patel@aah.org

    Krishna Joshi, MD

    Not yet recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Ashlynn Solomon, Ashlynn.Solomon@Pennmedicine.upenn.edu

    Brett Cucchiara, MD

    Not yet recruiting

  • Banner University Medical Center - Phoenix

    Phoenix, Arizona, 85006

    Hira Ismail, hirai@arizona.edu

    Daniel Cavalcanti, MD

    Not yet recruiting

  • Mayo Clinic

    Phoenix, Arizona, 85054

    Debbie Ryan, ryan.debra29@mayo.edu

    Benard Bendok, MD

    Not yet recruiting

  • Oregon Health & Science University Hospital

    Portland, Oregon, 97239

    Megan Pattle, rossme@ohsu.edu

    Jesse Liu, MD

    Not yet recruiting

  • UC Davis Medical Center

    Sacramento, California, 95817

    Savina Nguyen, savnguyen@ucdavis.edu

    Ben Waldau, MD

    Not yet recruiting

  • University of Utah Healthcare

    Salt Lake City, Utah, 84132

    Andrew Grandmange, Andrew.Grandemange@hsc.utah.edu

    Ramesh Grandhi, MD

    Not yet recruiting

  • Harborview Medical Center

    Seattle, Washington, 98104

    Lauren Klein, lrklein@uw.edu

    David Tirschwell, MD

    Not yet recruiting

  • Avera McKennan Hospital & University Health Center

    Sioux Falls, South Dakota, 57105

    Cassidy Kaiser, Cassidy.Kaiser@avera.org

    Randy Bell, MD

    Not yet recruiting

  • SSM Health St. Louis University Hospital

    St Louis, Missouri, 63104

    Edwin Akomaning, edwin.akomaning@health.slu.edu

    Diana Greene-Chandos, MD

    Not yet recruiting

  • Washington University - Barnes Jewish Hospital

    St Louis, Missouri, 63110

    Porche Braun, braunp@wustl.edu

    Raj Dhar, MD

    Not yet recruiting

  • Overlook Medical Center

    Summit, New Jersey, 07901

    Juliana Colecchia, juliana.colecchia@atlantichealth.org

    Paul Saphier, MD

    Not yet recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606

    Sai Priyanka Annadasu, 813-844-1053, sannadasu@tgh.org

    Kunal Vakharia, MD

    Recruiting

  • Baylor Scott & White Medical Center

    Temple, Texas, 76508

    Michelle Vanecek, michelle.vanecek@bswhealth.org

    Ethan Benardete, MD

    Recruiting

  • Banner University Medical Center - Tucson Campus

    Tucson, Arizona, 85719

    Kylie Lew, klew@arizona.edu

    Michael Avery, MD

    Not yet recruiting

  • John Muir Medical Center - Walnut Creek Campus

    Walnut Creek, California, 94598

    Melanie Aaron, Melenie.aaron@johnmuirhealth.com

    Benjamin Yim, MD

    Not yet recruiting

Other trials in United States

About this study

Official title: 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).

Being tested
Endoscopic ICH evacuation, Standard Medical Treatment
Keywords
Basal Ganglia, SCUBA, Intracerebral Hemorrhage
Medical subject headings
Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic ICH evacuationProcedure or surgery

    Also called SCUBA

    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 TreatmentOther

    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.

Study groups in NCT07260916
Study groupRoleWhat they receive
Endoscopic ICH evacuation (SCUBA) and Standard Medical TreatmentExperimentalParticipants will be treated with SCUBA and Standard Medical Treatment
Receives: Procedure: Endoscopic ICH evacuation; Other: Standard Medical Treatment
Standard Medical TreatmentPlacebo comparatorParticipants will be treated with Standard Medical Treatment
Receives: Other: Standard Medical Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 180

  2. Mortality (all-cause)

    Number of mortalities, for any reason, at day 30

    Measured: Day 30

Secondary outcomes (5)

  1. Number of successful endoscopic clot removal

    Successful endoscopic clot removal to ≤10 mL remaining clot

    Measured: during procedure

  2. Volume of clot remaining post endoscopic clot removal

    Volume of clot remaining on follow-up 24-hour CT scan post endoscopic clot removal

    Measured: 24 hours post procedure

  3. Number of post-procedural complications adverse events

    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.

    Measured: up to 30 days

  4. Number of CNS infection

    CNS infection attributed to surgery

    Measured: Day 30

  5. Peri-cavity edema (PCE)

    PCE on the 24-hour CT scan

    Measured: 24 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2025
  2. Study start10 Jul 2026
  3. Primary completion29 Jan 2029 (estimated)
  4. Study completion31 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07260916
Sponsor's protocol ID
GCO 23-1905
Other IDs
1UG3NS138638-01A1
Acronym
MINUTE
Status last verified
Sep 2026
First submitted
7 Nov 2025
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification.

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic ICH evacuation and Standard Medical Treatment in people with Basal Ganglia Intracerebral Hemorrhage, run by Weill Medical College of Cornell University at 44 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ally Qi, MPH (209-330-3024, alq4003@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Utility-Weighted Modified Rankin Scale (UW-mRS) (time frame: Day 180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07260916.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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