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Precise Image for Pediatrics
Sponsor: Philips Clinical & Medical Affairs Global
Summary
The purpose of this clinical study is to evaluate the performance of the Precise Image reconstruction algorithm in pediatric patients (specifically, head and body CT imaging of patients from 18 months up to and including 18 years of age). Clinical data generated from this study is intended to support a proposed expansion of the intended population of Precise Image. The study has two objectives: 1. To evaluate the image quality and diagnostic confidence of Precise Image compared to the standard-of-care reference (iDose4) for: * Head and body CT images of pediatric patients (from 18 months up to and including 18 years of age). 2. To demonstrate non-inferiority of Precise Image to iDose4 for the relevant anatomy and resolution groups.
Official title: Clinical Study for Precise Image for Pediatrics for Incisive CT and CT 5300 Systems
Key Details
Gender
All
Age Range
18 Months - 18 Years
Study Type
OBSERVATIONAL
Enrollment
168
Start Date
2026-01-31
Completion Date
2026-09-01
Last Updated
2026-01-05
Healthy Volunteers
No