ClinicalTrials.gg
RecruitingNCT07260916MINUTEUpdated Sep 15, 2026

Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation

An interventional study of Endoscopic ICH evacuation and Standard Medical Treatment in Basal Ganglia Intracerebral Hemorrhage, sponsored by Weill Medical College of Cornell University. Recruiting at 44 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 109 studies in Cerebral Hemorrhage with a site in United States — 31 open to participants now, 42 under way, 6 of them phase 3. Cerebral Hemorrhage · United States.

Planned enrollment
17th of 71
300 · median 60
Started
2026
with 9 others
No phase
25 of 109
9 open now
Primary completion
2029-01
later than 29 of 41 live
Registered
99th of 109
by date

Among the 109 studies in Cerebral Hemorrhage with a site in United States, this one is the 17th largest by planned enrollment of the 71 interventional ones that give a count, is one of 10 that started in 2026, is one of 25 with no phase, reaches primary completion later than 29 of the 41 other live ones, and was the 99th registered.

Cerebral Hemorrhage

457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.

Browse Cerebral Hemorrhage studies →

Open to participants now

31 of the 109 studies in Cerebral Hemorrhage with a site in United States are open now. Recruiting first, the newest first:

25 more — sign in →

All 31 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 112 Cerebral Hemorrhage studies recruiting now, 58 (52%) set no upper age limit and 9 (8%) stop at 75 or younger; 1 takes children under 18; 6 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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).

03

Conditions studied

  • Basal Ganglia Intracerebral Hemorrhage

Browse trials for

Keywords

  • Basal Ganglia
  • SCUBA
  • Intracerebral Hemorrhage
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. 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

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 (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. 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 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment

    Participants will be treated with SCUBA and Standard Medical Treatment

    Procedure: Endoscopic ICH evacuation · Other: Standard Medical Treatment

  • Placebo comparator
    Standard Medical Treatment

    Participants will be treated with Standard Medical Treatment

    Other: Standard Medical Treatment

Interventions

  • ProcedureEndoscopic 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.

    Also known as: SCUBA

  • OtherStandard 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.

06

What researchers measure

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.

    Time frame: Day 180

  2. Mortality (all-cause)

    Number of mortalities, for any reason, at day 30

    Time frame: Day 30

Secondary outcomes

  1. Number of successful endoscopic clot removal

    Successful endoscopic clot removal to ≤10 mL remaining clot

    Time frame: 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

    Time frame: 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.

    Time frame: up to 30 days

  4. Number of CNS infection

    CNS infection attributed to surgery

    Time frame: Day 30

  5. Peri-cavity edema (PCE)

    PCE on the 24-hour CT scan

    Time frame: 24 hour

07

Study locations

10 of 44 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification.

Supporting information: Study protocol, Statistical analysis plan

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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Jan 2029, 30 months after the start.

Of 76 non-industry interventional studies with no phase under Cerebral Hemorrhage, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 58. This study's planned 30 months is below that.

Counting every sponsor, half of 84 studies reached it within 38 months; a quarter within 19 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2025
First posted
Dec 3, 2025
StartActual
Jul 10, 2026
Primary completionEst.
Jan 29, 2029
CompletionEst.
Jul 31, 2030
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07260916
Responsible party
Sponsor
First posted
Dec 3, 2025
Start date
Jul 10, 2026
Primary completion
Jan 29, 2029 (estimated)
Completion
Jul 31, 2030 (estimated)
Last update
Sep 15, 2026

Study contacts

Ally Qi, MPH
Contact
alq4003@med.cornell.edu
209-330-3024
Cynthia Nguyen, MsCR
Contact
cyn4002@med.cornell.edu
J Mocco, MD, MS
principal investigator · Weill Medical College of Cornell University
Magdy Selim, MD, PhD
principal investigator · Beth Israel Deaconess Medical Center
Sharon Yeatts, PhD
principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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