Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06697808
Status
Recruiting

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Study Details

To improve patient selection for head CT, a safe and high sensitivity screening neuroimaging modality is needed. Currently many clinicians must make treatment decisions based solely on the patients clinical exam, which has low sensitivity and specificity and low inter-rater reliability. This study is being done to learn more about B-mode cranial point-of-care ultrasound (cPOCUS). Ultrasound has several advantages. It is a safe, non- invasive, low-cost, fast and portable bedside tool without ionizing radiation exposure.

Key Dates

Start date
Nov 24, 2024
Status verified
Aug 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
169 participants (estimated)

Primary Outcome Measure

Diagnostic Accuracy of Cranial Point-of-Care Ultrasound [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atrium Health Carolinas Medical CenterCharlotteNorth Carolina28203
Denise Fraga, MD
704-355-3181

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