Transcranial Ultrasound Via Sonolucent Cranioplasty

Cranioplasty Clinical Trial

Official title:

Transcranial Ultrasound Via Sonolucent Cranioplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06097845
• Other study ID #: 22-0873
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2023
• Est. completion date: August 1, 2026

Study information

• Verified date: October 2023
• Source: Northwell Health
• Contact: Netanel Ben-Shalom, MD
• Phone: 212-434-3900
• Email: nbenshalom[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cranioplasty

Intervention

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.

Locations

Country	Name	City	State
United States	Lenox Hill Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of Neuroanatomy accuracy of TCUS	Accuracy metrics related to identification and measurement of neuroanatomy structures using Trasncranial Ultrasound	12 months
Primary	Diagnostic accuracy of TCUS	Accuracy metrics related to detection of postoperative complications using Trasncranial Ultrasound	12 months