Back to search results

Transcranial Ultrasound After Minimally Invasive Intracerebral Hemorrhage Evacuation

This study is looking at a new way to monitor bleeding after surgery for a type of stroke called intracerebral hemorrhage (ICH). ICH is bleeding inside the brain. After surgery to remove the blood, doctors usually use CT scans to check for new bleeding. This study will use a special implant called ClearFit, which is already approved for use, during surgery. This implant allows doctors to use transcranial ultrasound (sound waves through the skull) to check for bleeding right at the patient's bedside. The study aims to see if this method can accurately detect and measure bleeding in patients who have had surgery for ICH. You might be able to join if you are 18 or older, have a certain size ICH, and are having minimally invasive surgery for it. The study will measure the presence of intracerebral hemorrhage at 6 months.

Study design
This is an interventional study with a planned enrollment of 25 participants. It is not specified if it is randomized or blinded.
What's involved
While you are an inpatient, the study team will try to perform transcranial ultrasonography through the ClearFit implant within 1 hour of neuroimaging.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for the presence of intracerebral hemorrhage at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05538286

Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation

Recruiting
NAAges 18+InterventionalDiagnostic
Icahn School of Medicine at Mount Sinai
~25 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:ClearFit implanttranscranial ultrasonography through sonolucent cranioplasty

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The presence of intracerebral hemorrhage
Measured over at 6 months

Conditions

Transcranial Ultrasound With Sonolucent Cranioplasty
TUSC

Explore related trials

Cerebral Hemorrhage

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Christopher P. Kellner, MD · PRINCIPAL_INVESTIGATOR · Mount Sinai Health System Department of Neurosurgery

Who to contact

Christopher P. Kellner, MD
[email protected]
(212) 241-6500
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Presence of spontaneous supratentorial ICH ≥20 mL
Age ≥18 years
National Institute of Health Stroke Scale (NIHSS) score ≥6
GCS score 5-15 at presentation
Undergoing minimally invasive intracerebral hemorrhage evacuation with sonolucent cranioplasty or hemicraniectomy with sonolucent cranioplasty

Exclusion

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
History of osteomyelitis
History of skull neoplasm
History of comminuted skull fractures
Infratentorial hemorrhage
Midbrain extension/involvement
Coagulopathy defined as INR \> 1.4, elevated aPTT, or concurrent use of direct oral anticoagulants or low molecular weight heparin at ICH onset; known hereditary or acquired hemorrhagic diathesis; coagulation factor deficiency; platelet count \< 100x103cells/mm3, or known platelet dysfunction
Inability to obtain consent from patient or appropriate surrogate (for patients without capacity)
Evidence of active infection indicated by fever ≥ 100.7F and/or open draining wound at the time of enrolment
Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 1 year
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 appointment schedule
Active drug or alcohol abuse that, in the opinion of the site investigator, would interfere with adherence to study enrolments
Pre-existing DNR/DNI status

What this trial measures

  • The presence of intracerebral hemorrhageat 6 months

    Accuracy of TUSC via ClearFit to detect the presence or absence of postoperative intracerebral hemorrhage compared to CT.