Precise Image for Musculoskeletal CT

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 acceptability of Precise Image compared to the standard-of-care reference (iDose4) for:

o Musculoskeletal CT images (shoulder, hip, knee) of adult patients (>18 years old). 2. To demonstrate non-inferiority of Precise Image to iDose4 for the planned resolution groups.

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Key information

Conditions

Computed Tomography

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 failed internal technical checks (e.g., corrupt files, failure to reconstruct).

Treatment and study plan

Primary outcomes

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 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.

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Collaborators

Philips Healthcare (Suzhou) Co., Ltd.

Registry information

Official study title

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

Important dates

Study start: 2027
Primary completion: 2027
Study completion: 2027
First posted: Jan 5, 2026
Registry last updated: Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Not yet recruiting