Transcranial Ultrasound Via Sonolucent Cranioplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Cranioplasty; Sonolucent Cranioplasty; Reconstructive Cranioplasty
• Intervention / Treatment: Diagnostic test: Transcranial Ultrasound

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tamika Wong, MPH; Phone Number: 212-434-4836; Email: twong4@northwell.edu
• Study Contact Backup: Name: Netanel Ben-Shalom, MD; Phone Number: 212-434-3900; Email: nbenshalom@northwell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10075
      • Recruiting
      • Lenox Hill Hospital
      • Contact: Tamika Wong, MPH; Phone Number: 212-434-4836; Email: twong4@northwell.edu
      • Sub-Investigator: Tamika Wong, MPH
      • Sub-Investigator: Olivia Albers, NP
      • Sub-Investigator: Randy D'Amico, MD
      • Sub-Investigator: Vadim Zhigin, PA
      • Contact: Netanel Ben-Shalom, MD; Phone Number: 212-434-3900; Email: nbenshalom@northwell.edu
      • Sub-Investigator: Heustein Sy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Transcranial Ultrasound; Ultrasound imaging will be performed by clinicians using FDA-approved ultrasound devices currently used in routine clinical practice.

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Netanel Ben-Shalom, MD, Lenox Hill Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Transcranial Ultrasound; SOC ultrasound; PMMA implant
• Other Study ID Numbers: 22-0873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No