Recruiting

Transcranial Ultrasound

Sponsor:

Northwell Health

Code:

NCT06097845

Conditions

Cranioplasty

Sonolucent Cranioplasty

Reconstructive Cranioplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcranial Ultrasound

Study Details

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

Study ID

NCT06097845

Start date

Jun 27, 2023

Status verified date

Sep, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Transcranial Ultrasound

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

Interventions

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.

Primary outcome measure

  • Identification of Neuroanatomy accuracy of TCUS [ Time Frame: 12 months ]
  • Diagnostic accuracy of TCUS [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Netanel Ben-Shalom, MD

212-434-3900nbenshalom@northwell.edu

Tamika Wong, MPH

212-434-4836twong4@northwell.edu

Locations

Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Contacts

Netanel Ben-Shalom, MD

212-434-3900nbenshalom@northwell.edu

Tamika Wong, MPH

212-434-4836twong4@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Sep 15, 2025

Last verified

Sep, 2025

Keywords

  • Transcranial Ultrasound
  • SOC ultrasound
  • PMMA implant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2025-09-15.