Clinical Study for P-MAR
ConditionComputed Tomography
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPhilips Clinical & Medical Affairs Global
About this trial
The purpose of this clinical study is to evaluate the performance of the P-MAR metal artifact reduction algorithm for CT imaging (with metal present) of adult patients (\>18 years old).
The study has two objectives:
1. To evaluate the extent of metal artifacts and diagnostic confidence, and overall image quality (independent of metal artifacts) of P-MAR compared to images without metal correction, and compared to O-MAR, for CT images (with metal present) of adult patients (\>18 years old). 2. To demonstrate non-inferiority of P-MAR compared to images without metal correction for the relevant metal 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.
Subject age: Above 18 years old.
Scans with metal present (orthopedic implants/joint prothesis, dental filling/implants, spine screw(s), pacemaker, coils, radiotherapy beads, surgical clips/staples, metal objects either outside the body or near air, etc.)
Disqualifiers
Subject age: 18 years old and below.
CT scans with no metal present.
CT scans with metal with motion artifacts.
Surview or Locator/Tracker.
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
The extent of metal artifacts and diagnostic confidence of P-MAR
The extent of metal artifacts and diagnostic confidence of P-MAR reconstructions is at least as good as (non-inferior to) images without metal correction, for CT images (with metal present) 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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