Precise Image for Interventional CT

Philips

Status: Not yet enrolling

Conditions: Computed Tomography

Study type: Observational

Funder types: Industry

Identifiers

NCT07317427

Precise Image for CCT

Details and patient eligibility

About

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 and procedural confidence of Precise Image compared to the standard-of-care reference (iDose4) for:

   • 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.