Precise Image for Musculoskeletal CT

December 18, 2025 updated by: Philips Clinical & Medical Affairs Global

Clinical Study for Precise Image for Musculoskeletal CT for Incisive CT and CT 5300 Systems

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

84

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

No

Sampling Method

Probability Sample

Study Population

Adults

Description

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.

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
Assessment of CT Image quality and diagnostic confidence of Precise Image via 5-point Likert Scale
Time Frame: Reading session at 4 months
The image quality and diagnostic confidence of Precise Image reconstructions is non-inferior to iDose4 reconstructions for musculoskeletal CT images of adult patients. 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

Collaborators and Investigators

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

Sponsor

Philips Clinical & Medical Affairs Global

Collaborators

Philips Healthcare (Suzhou) Co., Ltd.

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)

January 31, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Precise Image for MSK

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.

Clinical Trials on Computed Tomography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe