Recruiting

Transcranial Ultrasound

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05538286

Conditions

Transcranial Ultrasound With Sonolucent Cranioplasty

TUSC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ClearFit implant

transcranial ultrasonography through sonolucent cranioplasty

Study Details

Brief summary:

Postoperative rebleeding is a major limitation of surgical evacuation for intracerebral hemorrhage (ICH). While computed tomography (CT) is the standard of care for postoperative hematoma cavity monitoring, CT requires significant physical and financial costs. Studies have demonstrated varying degrees of efficacy when using transcranial ultrasound to measure ICH volume. Recently, synthetic implants for cranioplasty have been shown to be safe and sonolucent. This study aims to evaluate the ability of transcranial ultrasound with sonolucent cranioplasty (TUSC) to detect and quantify bleeding in postoperative ICH patients.

Conditions

Transcranial Ultrasound With Sonolucent Cranioplasty

TUSC

Study ID

NCT05538286

Start date

Sep 23, 2022

Status verified date

Apr, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: transcranial ultrasonography through sonolucent cranioplasty

All surgical procedures and implants in this protocol are standard of care.

Interventions

ClearFit implant

The ClearFit implant is an FDA cleared implant in regular use in the United States. The ClearFit implant and other PMMA cranioplasty implants manufactured by Longeviti have been reported to be safe and effective as cranial implants that permit transcranial ultrasound to be performed. The PMMA cranioplasty implant (Longeviti Neuro Solutions, Hunt Valley, MD) is clear, sonolucent, and was recently shown to be safe and effective in transcranial ultrasonography for bypass patency assessment. The ClearFit cranioplasty being used in this study is industry standard of care.

transcranial ultrasonography through sonolucent cranioplasty

The implantation of the ClearFit PMMA sonolucent implant permits TUSC to be performed at the bedside for patients in both the in-patient and outpatient settings. While the patient is an inpatient, the clinical or research teams will attempt to perform TUSC within 1 hour of neuroimaging if that neuroimaging is performed at a time when a trained ultrasound operator is present.

Primary outcome measure

  • The presence of intracerebral hemorrhage [ Time Frame: at 6 months ]

Central Contacts and Locations

Central contacts

Christopher P. Kellner, MD

(212) 241-6500christopher.kellner@mountsinai.org

Sydney Edwards

Sydney.Edwards@mountsinai.org

Locations

Mount Sinai Health System

Recruiting

New York, New York, United States, 10029

Contacts

Christopher P. Kellner, MD

christopher.kellner@mountsinai.org

Sydney Edwards

Sydney.Edwards@mountsinai.org

Principal Investigator:

Christopher P. Kellner

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

May 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-05-05.