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NCT Number: NCT06097845

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lenox Hill Hospital

New York, 10075, United States

Location status: Recruiting

Location contact

Heustein Sy, MD

SUB_INVESTIGATOR

Netanel Ben-Shalom, MD

CONTACT

[email protected]

212-434-3900

Olivia Albers, NP

SUB_INVESTIGATOR

Randy D'Amico, MD

SUB_INVESTIGATOR

Tamika Wong, MPH

CONTACT

[email protected]

212-434-4836

Tamika Wong, MPH

SUB_INVESTIGATOR

Vadim Zhigin, PA

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients who are pregnant

Treatment and study plan

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.

Primary outcomes

  1. Identification of Neuroanatomy accuracy of TCUS

    Time frame: 12 months

    Accuracy metrics related to identification and measurement of neuroanatomy structures using Trasncranial Ultrasound

  2. Diagnostic accuracy of TCUS

    Time frame: 12 months

    Accuracy metrics related to detection of postoperative complications using Trasncranial Ultrasound

Study contacts

Contact information is provided by the study sponsor or research team.

Netanel Ben-Shalom, MD

CONTACT

[email protected]

212-434-3900

Tamika Wong, MPH

CONTACT

[email protected]

212-434-4836

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 24, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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