Could a simple ultrasound replace costly CT scans after brain bleed surgery?

NCT ID NCT05538286

Diagnosis Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new way to check for bleeding after stroke surgery using a special ultrasound through a clear skull implant. It aims to see if this method is as accurate as a CT scan, which is the current standard but is expensive and time-consuming. About 25 adults who had a brain bleed and are getting a clear skull implant will participate. If successful, this could make monitoring safer and more accessible.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * 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 criteria: * 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

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Conditions

The condition(s) this trial relates to.

intracerebral hemorrhage tuberous sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Transcranial ultrasound with sonolucent cranioplasty TUSC

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a simple ultrasound replace costly CT scans after brain bleed surgery?

What the study statuses mean