Precise Image for Musculoskeletal CT
ConditionComputed Tomography
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
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 for musculoskeletal CT imaging (shoulder, hip, knee) of adult patients (\>18 years old). Clinical data generated from this study is intended to support a proposed expansion of the Indications for Use of Precise Image.
The study has two objectives:
1. To evaluate the image quality and diagnostic acceptability of Precise Image compared to the standard-of-care reference (iDose4) for:
o Musculoskeletal CT images (shoulder, hip, knee) of adult patients (\>18 years old). 2. To demonstrate non-inferiority of Precise Image to iDose4 for the planned 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: Above 18 years old.
Disqualifiers
Subject age: 18 years old and below.
Scans that were acquired using generic 'Body' scan type (as Precise Image does not support generic '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 population
Adults
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 of Precise Image via 5-point Likert Scale
The image quality and diagnostic acceptability of Precise Image reconstructions are at least as good as (non-inferior to) iDose4 reconstructions for musculoskeletal CT images (shoulder, hip, knee) of adult patients (\>18 years old). 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
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