Overview
Prospective, multicenter, Level 2 diagnostic accuracy cohort study
Transcranioplasty Ultrasound (TCUS) Through ClearFit Sonolucent Cranial Implants for Monitoring Postoperative Subdural Hematomas
Principles
1
Standard care is never altered.
All clinically ordered CT and MRI happen as usual. TCUS is additional.
2
Reads are independent and blinded.
The TCUS reader never sees the paired CT/MRI; the neuroradiology reader never sees the TCUS. Both lock before comparison.
3
Partial view, stated as such.
TCUS sees the region under the implant window. The study measures what that region shows and what whole-brain imaging adds; it does not assume the window sees everything.
Who is who
Coordinating center
The Ohio State University Department of Neurosurgery
Confirmed
Principal Investigator
Shahid M. Nimjee, MD, PhD
Confirmed
Central imaging core — TCUS reads
Andrei Alexandrov, MD
Pending confirmation
Central imaging core — Neuroradiology reads
Elizabeth Westfall, MD
Pending confirmation
Statistical analysis
University of Iowa
Status not provided
Sponsor / device manufacturer
Longeviti Neuro Solutions, Baltimore, MD
Confirmed
Imaging-core director
Not yet named in protocol
Under review
Coordinating-center data manager
Not yet named in protocol
Under review