NCT06097845

Transcranial Ultrasound Via Sonolucent Cranioplasty

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Transcranial Ultrasound via Sonolucent Cranioplasty is a prospective, single arm, observational, open label (non-blinded) study to collect real world evidence on the use of transcranial ultrasound via sonolucent cranioplasty.

Detailed description

Standard of care (SOC) imaging techniques routinely used for neurosurgical monitoring, namely computed tomography (CT) and magnetic resonance imaging (MRI), present numerous patient, provider, and institutional burdens associated with transport, invasiveness, contrast administration, radiation exposure, imaging delay, and overall global costs. Ultrasound represents a promising alternative that overcomes many of these disadvantages being noninvasive, low-risk, real-time and portable, but is limited by the acoustic impedance of autologous cranial bone. Recently, material innovations enabling both transparent and sonolucent polymethyl methacrylate (PMMA) - a material commonly used for cranial reconstruction with a longstanding history of safety - have facilitated ultrasound windows within patients already receiving cranioplasty as standard of care. Early results applying transcranioplasty ultrasound (TCUS) through sonolucent cranial plates have been encouraging in regard to agreement with SOC imaging and advanced doppler capabilities. That said, limited published data exists commensurate with the novelty of the technique, therefore investigators herein aim to address this paucity by investigating the feasibility and efficacy of TCUS as compared to standard of care postoperative imaging modalities (i.e. MRI \& CT) in a prospective, quality control study.

Conditions

• Cranioplasty
• Sonolucent Cranioplasty
• Reconstructive Cranioplasty

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transcranial Ultrasound	Patients who underwent reconstructive sonolucent cranioplasty will receive standard of care postoperative imaging (i.e. CT, MRI) in addition to ultrasound imaging. Ultrasound imaging will be performed by clinicians using FDA-approved ultrasound devices (GE Venue Go, Fujifilm Sonosite X-Porte, GE Volusion E10 and Clarius HD3 etc.) currently used in routine clinical practice.

Timeline

• Start date: 2023-06-27
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2023-10-24
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study