Transcranial Ultrasound Via Sonolucent Cranioplasty

Conditions

• Cranioplasty
• Reconstructive Cranioplasty
• Sonolucent Cranioplasty

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Jun 27, 2023

Status verified

Sep 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

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

Primary Outcome Measure

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

Central Contacts

• Netanel Ben-Shalom, MD
  212-434-3900
  [email protected]
• Tamika Wong, MPH
  212-434-4836
  [email protected]

Locations (1)

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