AI Based Metal Artifact Reduction-PMAR

NCT07619404 | Not Yet Recruiting

• 1 other identifier: SEF-2025-301454
• Study Type: observational
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lmbar Spine With Screws

Outcome Measures

Primary Outcomes (1)

• Image Quality-4 Likert Scale

  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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study participants from Beijing Jishuitan Hospital.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead
• Beijing Jishuitan Hospital: collaborator

Central Study Contacts

Zhu Xu Chen

CONTACT

+8618612235763; radiology888@aliyun.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05