Precise Image for Interventional CT

The purpose of this clinical study is to assess the performance of the Precise Image reconstruction algorithm on interventional CT images acquired from adult patients (>18 years old). The analysis will focus on the performance of Precise Image for scans in which procedural instruments (e.g., needle, probe, screw) are present. 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 for procedural guidance of Precise Image compared to the standard-of-care reference (iDose4) for:

o Interventional CT images of adult patients (>18 years old). 2. To demonstrate non-inferiority of Precise Image to iDose4 for the relevant interventional CT images.

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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 clinical scans.
Subject age: >18 years old.
Presence of procedural instrument(s) (e.g., needle, probe, screw) in the CT images.

Exclusion criteria

Subject age: 18 years old and below.
Absence of procedural instrument(s) (e.g., needle, probe, screw) in the CT images.
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 interventional radiologists have deemed non-suitable for procedural guidance.
Scans that the site interventional radiologists have deemed non-suitable for procedural guidance.

Treatment and study plan

Primary outcomes

Assessment of the CT image quality of Precise Image reconstructions via a 5-point Likert Scale

Time frame: Reading session at 4 months

The image quality of Precise Image reconstructions will be considered at least as good as (non-inferior to) that of iDose4 reconstructions for interventional CT images (CCT single, continuous, fluoro) of adult patients (>18 years old)

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 Interventional 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