Transcranial Ultrasound Via Sonolucent Cranioplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transcranial Ultrasound Via Sonolucent Cranioplasty

Conditions
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Cranioplasty, Sonolucent Cranioplasty, Reconstructive Cranioplasty

Intervention / Treatment
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* Diagnostic Test: Transcranial Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Patients who are undergoing reconstructive sonolucent cranioplasty as standard of care. Male or female, aged ≥ 18. Exclusion Criteria: 1. Patients who are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial Ultrasound<br>Ultrasound imaging will be performed by clinicians using FDA-approved ultrasound devices currently used in routine clinical practice. | Diagnostic Test: Transcranial Ultrasound<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of Neuroanatomy accuracy of TCUS | Accuracy metrics related to identification and measurement of neuroanatomy structures using Trasncranial Ultrasound | 12 months | 
| Diagnostic accuracy of TCUS | Accuracy metrics related to detection of postoperative complications using Trasncranial Ultrasound | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Ultrasound, SOC ultrasound, PMMA implant