Lmbar Spine With ScrewsNCT07619404
AI Based Metal Artifact Reduction-PMAR
An observational study of Lmbar Spine With Screws, run by Philips Clinical & Medical Affairs Global.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lmbar Spine With Screws
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: The study participants from Beijing Jishuitan Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Lmbar Spine With Screws
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From the date of image reconstruction completion until the date of image read completion. Anticipate 2Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lmbar Spine With ScrewsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Jishuitan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619404
- Sponsor's protocol ID
- SEF-2025-301454
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of AI Based Metal Artifact Reduction and Its Comparison With Orthopedic Metal Artifact Reduction (O-MAR) and Conventional Image
- ClinicalTrials.gov ID
- NCT07619404
- Acronym / sponsor ID
- SEF-2025-301454
- Conditions
- Lmbar Spine With Screws
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Jishuitan Hospital
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study participants from Beijing Jishuitan Hospital.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Lmbar Spine With Screws, run by Philips Clinical & Medical Affairs Global.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhu Xu Chen (+8618612235763, radiology888@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality-4 Likert Scale (time frame: From the date of image reconstruction completion until the date of image read completion. Anticipate 2Months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.