RecruitingNot ApplicableNCT06097845

Transcranial Ultrasound Via Sonolucent Cranioplasty


Sponsor

Northwell Health

Enrollment

50 participants

Start Date

Jun 27, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria1

  • \. Patients who are pregnant

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Interventions

DIAGNOSTIC_TESTTranscranial 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(1)

Lenox Hill Hospital

New York, New York, United States

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NCT06097845


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