Precise Image for Interventional 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 assess the performance of the Precise Image reconstruction algorithm on interventional CT images acquired from adult patients (\>18 years old). The analysis will focus on the performance of Precise Image for scans in which procedural instruments (e.g., needle, probe, screw) are present. 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 for procedural guidance of Precise Image compared to the standard-of-care reference (iDose4) for:
o Interventional CT images of adult patients (\>18 years old). 2. To demonstrate non-inferiority of Precise Image to iDose4 for the relevant interventional CT images.
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 clinical scans.
Subject age: >18 years old.
Presence of procedural instrument(s) (e.g., needle, probe, screw) in the CT images.
Disqualifiers
Subject age: 18 years old and below.
Absence of procedural instrument(s) (e.g., needle, probe, screw) in the CT images.
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 interventional radiologists have deemed non-suitable for procedural guidance.
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 the CT image quality of Precise Image reconstructions via a 5-point Likert Scale
The image quality of Precise Image reconstructions will be considered at least as good as (non-inferior to) that of iDose4 reconstructions for interventional CT images (CCT single, continuous, fluoro) of adult patients (\>18 years old)
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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