Transcranial Ultrasound Via Sonolucent Cranioplasty

NCT06097845 | Recruiting FDA Device

• 1 other identifier: 22-0873
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cranioplasty; Sonolucent Cranioplasty; Reconstructive Cranioplasty

Keywords

Transcranial Ultrasound; SOC ultrasound; PMMA implant

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Transcranial Ultrasound

EXPERIMENTAL

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

Diagnostic Test: Transcranial Ultrasound

Interventions

Transcranial Ultrasound DIAGNOSTIC_TEST

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.

Transcranial Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Patients who are pregnant

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

Study Officials

• Netanel Ben-Shalom, MD

  Lenox Hill Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Netanel Ben-Shalom, MD

CONTACT

212-434-3900; nbenshalom@northwell.edu

Tamika Wong, MPH

CONTACT

212-434-4836; twong4@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 24, 2023
• Study Start: June 27, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)