Transcranial Ultrasound Via Sonolucent Cranioplasty

Not Applicable

Recruiting

• Conditions: Cranioplasty; Sonolucent Cranioplasty; Reconstructive Cranioplasty
• Interventions: Diagnostic Test: Transcranial Ultrasound

• Registration Number: NCT06097845
• Lead Sponsor: Northwell Health

Brief 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.

Study Timeline

• Study Start: 2023-06-27
• Study First Submitted: 2023-09-19
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-19
• Last Update Submitted: 2023-10-19
• Study First Posted: 2023-10-24
• Last Update Posted: 2023-10-24
• Primary Completion: 2025-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Patients who are undergoing reconstructive sonolucent cranioplasty as standard of care.
4. Male or female, aged ≥ 18.

Exclusion Criteria

1. Patients who are pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcranial Ultrasound	Transcranial Ultrasound	Ultrasound imaging will be performed by clinicians using FDA-approved ultrasound devices currently used in routine clinical practice.

Primary Outcome Measures

Name	Time	Method
Identification of Neuroanatomy accuracy of TCUS	12 months	Accuracy metrics related to identification and measurement of neuroanatomy structures using Trasncranial Ultrasound
Diagnostic accuracy of TCUS	12 months	Accuracy metrics related to detection of postoperative complications using Trasncranial Ultrasound

Trial Locations

Locations (1)

Lenox Hill Hospital; 🇺🇸 New York, New York, United States