Precise Image for Musculoskeletal CT

NCT ID: NCT07317453

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-10-01

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. To evaluate the image quality and diagnostic confidence of Precise Image compared to the standard-of-care reference (iDose4) for:

• Musculoskeletal CT images (shoulder, hip, knee) of adult patients (>18 years old).

2. To demonstrate non-inferiority of Precise Image to iDose4 for the relevant resolution groups.

Conditions

Computed Tomography

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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 for the applicable anatomies.
• Subject age: Above 18 years old.

Exclusion Criteria

• 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 are not completed due to technical difficulties.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Healthcare (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Precise Image for MSK

Identifier Type: -

Identifier Source: org_study_id