Precise Image for Musculoskeletal CT

NCT07317453 | Not Yet Recruiting

• 1 other identifier: SEF-2025-301307
• Study Type: observational
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical study is to evaluate the performance of the Precise Image reconstruction algorithm for musculoskeletal CT imaging (shoulder, hip, knee) of adult patients (\>18 years old). Clinical data generated from this study is intended to support a proposed expansion of the Indications for Use of Precise Image. The study has two objectives:

1. 1.To evaluate the image quality and diagnostic acceptability of Precise Image compared to the standard-of-care reference (iDose4) for:
2. 2.To demonstrate non-inferiority of Precise Image to iDose4 for the planned resolution groups.

Conditions

Computed Tomography

Outcome Measures

Primary Outcomes (1)

• Assessment of CT Image quality and diagnostic confidence of Precise Image via 5-point Likert Scale

  The image quality and diagnostic acceptability of Precise Image reconstructions are at least as good as (non-inferior to) iDose4 reconstructions for musculoskeletal CT images (shoulder, hip, knee) of adult patients (\>18 years old). Measurement will be done via 5-point Likert Scale for Image Quality where 5 is excellent and 1 is poor image quality.

  Reading session at 4 months

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults

You may qualify if:

• Subjects scanned by FDA-cleared and marketed Philips Incisive CT or CT 5300 systems, and according to the department standard of care clinical protocols for the applicable anatomies.
• Subject age: Above 18 years old.

You may not qualify if:

• Subject age: 18 years old and below.
• Scans that were acquired using generic 'Body' scan type (as Precise Image does not support generic 'Body' scan types).
• Scans that were acquired using a kilovoltage peak of 70 kVp (as Precise Image does not support a kilovoltage peak lower than 80 kVp).
• Scans that the site radiologists have deemed as non-diagnostic image quality in standard practice (e.g. patient movement).
• Scans that failed internal technical checks (e.g., corrupt files, failure to reconstruct).

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead
• Philips Healthcare (Suzhou) Co., Ltd.: collaborator

Study Design

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

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: January 5, 2026
• Study Start (Estimated): January 31, 2027
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08