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
This trial does not accept healthy volunteersQualifiers
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).
Head scans (brain and sinus/facial/orbits) acquired with a kilovoltage peak (kVp) outside the range of 100-120 kVp (as Precise Image does not support kVp settings outside this range for these clinical 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).
Trial population
Pediatrics
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Assessment of CT Image quality and diagnostic confidence via 5-point Likert Scale
The image quality and diagnostic acceptability of Precise Image reconstructions are non-inferior to iDose4 reconstructions for head and body CT images of pediatric patients (from 18 months up to and including 18 years of age). Measurement will be done via 5-point Likert Scale for Image Quality where 5 is excellent and 1 is poor image quality.
Time frame
Reading session at 4 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Philips Clinical & Medical Affairs Global
Lead sponsor
Philips Healthcare (Suzhou) Co., Ltd.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: