Transcranial Ultrasound Via Sonolucent Cranioplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwell Health
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Transcranial Ultrasound
Diagnostic testPatients 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Transcranial UltrasoundExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Identification of Neuroanatomy accuracy of TCUS
Accuracy metrics related to identification and measurement of neuroanatomy structures using Trasncranial Ultrasound
Time frame
12 months2
Diagnostic accuracy of TCUS
Accuracy metrics related to detection of postoperative complications using Trasncranial Ultrasound
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov