Clinical Study of CT 5400 RT for Precise Image Validation

Not Applicable

Completed

• Conditions: Precise Image (AI Reconstruction Feature of CT 5400 RT System)
• Interventions: Diagnostic Test: Precise Image

• Registration Number: NCT06589934
• Lead Sponsor: Philips Clinical & Medical Affairs Global

Brief Summary

The purpose of this study is to evaluate the effectiveness of the Precise Image (PI), an AI feature of CT 5400 RT System

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Study Start: 2025-01-25
• Primary Completion: 2025-01-25
• Study Completion: 2025-03-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 30 image raw data generated from CT 5400 RT system validation clinical trial (protocol name: Clinical study of CT 5400 RT for system validation, ClinicalTrials.gov ID: NCT06466577)
• Applicable body parts include: head, neck, chest, abdomen and coronary

Exclusion Criteria

• Raw data is considered inappropriate for inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Image quality	Precise Image	Diagnostic Test -Good and excellent rate of PI image quality is greater than or equal to 95%. PI image quality will be assessed by using the retrospective image raw data obtained from CT 5400 RT (applicable body parts include: head, neck, chest, abdomen and coronary)

Primary Outcome Measures

Name	Time	Method
Clinical image quality(IQ)	14 days (anticipated)	Image quality will be assessed by Likert score (1-5)

Trial Locations

Locations (1)

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai, China