Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07317466
Brief 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.
Detailed Description:
This is a retrospective, observational, multi-site, controlled, blinded, non-inferiority clinical investigation.
Precise Image is a reconstruction mode using a trained deep learning neural network to generate images with reduced noise and improved low contrast detectability at lower doses compared with standard FBP (filter back projection) reconstruction.
Pediatric subjects (from 18 months up to and including 18 years of age) scanned by the FDA-cleared Philips Incisive CT (K212441) or CT 5300 (K232491) systems.
The study will include reconstructed images of 168 CT scans in total. For each of the anatomies and resolutions, 42 scans will be used.
Study:
NCT07317466
Study Brief:
Protocol Section:
NCT07317466