Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation

NARecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

September 23, 2022

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Transcranial Ultrasound With Sonolucent CranioplastyTUSC
Interventions
DEVICE

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.

PROCEDURE

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.

Trial Locations (1)

10029

RECRUITING

Mount Sinai Health System, New York

All Listed Sponsors
lead

Icahn School of Medicine at Mount Sinai

OTHER