Clinical Study for P-MAR (Precise MAR)

December 18, 2025 updated by: Philips Clinical & Medical Affairs Global

Clinical Study for P-MAR Metal Artifact Reduction Algorithm for Incisive CT and CT 5300 Systems

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adults

Description

Inclusion Criteria:

  • 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.)

Exclusion Criteria:

  • Subject age: 18 years old and below.
  • CT scans with no metal present.
  • CT scans with metal with motion artifacts.
  • Surview or Locator/Tracker.
  • CT scans performed utilizing respiratory gating (e.g., "pulmo gating").
  • CT scans performed utilizing cardiac gating.
  • CT Perfusion scans.
  • CCT scans.
  • Scans that the site radiologists have deemed as non-diagnostic image quality in standard practice (e.g. patient movement).
  • Scans that are not completed due to technical difficulties.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The extent of metal artifacts and diagnostic confidence of P-MAR
Time Frame: Reading session at 4 months
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).
Reading session at 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Clinical & Medical Affairs Global

Collaborators

Philips Healthcare (Suzhou) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 31, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Precise MAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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