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Clinical Study for P-MAR

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07317479
Acronym
Precise MAR
Enrollment
120
Registered
2026-01-05
Start date
2026-01-31
Completion date
2026-10-01
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Computed Tomography

Brief summary

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.

Interventions

None listed

Sponsors

Philips Healthcare (Suzhou) Co., Ltd.
CollaboratorINDUSTRY
Philips Clinical & Medical Affairs Global
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The extent of metal artifacts and diagnostic confidence of P-MARReading session at 4 monthsThe 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026