Precise Image for Pediatrics
ConditionComputed Tomography
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-18
SponsorPhilips Clinical & Medical Affairs Global
About this trial
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.
Eligibility criteria
Qualifiers
Subjects scanned by FDA-cleared and marketed Philips Incisive CT or CT 5300 systems, and according to the department standard of care clinical protocols for the applicable anatomies.
Subject age: From 18 months up to and including 18 years of age.
Disqualifiers
Subject age: Below 18 months and above 18 years of age.
Scans that were acquired using generic 'Head' and 'Body' scan types (as Precise Image does not support generic 'Head' and 'Body' scan types).
Scans that were acquired using a kilovoltage peak of 70 kVp (as Precise Image does not support a kilovoltage peak lower than 80 kVp).
Scans that the site radiologists have deemed as non-diagnostic image quality in standard practice (e.g. patient movement).
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Locations
Sponsors and collaborators
Philips Clinical & Medical Affairs Global
Lead sponsor
Philips Healthcare (Suzhou) Co., Ltd.
Collaborator
Source ClinicalTrials.gov