AI Based Metal Artifact Reduction-PMAR

May 27, 2026 updated by: Philips Clinical & Medical Affairs Global

Clinical Application of AI Based Metal Artifact Reduction and Its Comparison With Orthopedic Metal Artifact Reduction (O-MAR) and Conventional Image

The study is going to enroll about 220 consecutive patients with screws in lumber spine after internal fixation surgery who underwent follow-up assessment using Incisive CT according to the department standard of care. Retrospective data sets will be reconstructed into conventional image, the O-MAR algorithm, and Precise-MAR. Three blinded, independent radiologists evaluate both qualitative and quantitative analysis of image quality of surrounding tissue and artifact. Statistical analysis included the Friedman test, Wilcoxon signed-rank test, and Levene test.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

N/A

Sampling Method

Non-Probability Sample

Study Population

The study participants from Beijing Jishuitan Hospital.

Description

Inclusion Criteria:

  1. Images come from patients aged ≥ 18 years,
  2. Images come from patients with screws in lumber spine after internal fixation surgery underwent follow up Incisive CT scan;
  3. Images come from patients who comply with the requirements of informed consent at the study site.

Exclusion Criteria:

  1. Patients with other metal objects inside or outside the body
  2. There is movement during the CT scan, causing by breathing etc. artifact affecting image quality
  3. Data is considered unsuitable for enrollment based on the investigator's evaluation due to incomplete clinical data or radiological information etc.

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
Image Quality-4 Likert Scale
Time Frame: From the date of image reconstruction completion until the date of image read completion. Anticipate 2Months.
The radiologist will evaluate the image quality using Likert scale on a scale ranging from 0(poor) to 4(good)
From the date of image reconstruction completion until the date of image read completion. Anticipate 2Months.

Collaborators and Investigators

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

Sponsor

Philips Clinical & Medical Affairs Global

Collaborators

Beijing Jishuitan Hospital

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)

June 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • SEF-2025-301454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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