- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06589934
Clinical Study of CT 5400 RT for Precise Image Validation
November 24, 2025 updated by: Philips Clinical & Medical Affairs Global
The purpose of this study is to evaluate the effectiveness of the Precise Image (PI), an AI feature of CT 5400 RT System
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200120
- Shanghai Public Health Clinical Center
-
-
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
Yes
Description
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 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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Image quality
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)
|
Image reconstruction software
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical image quality(IQ)
Time Frame: 14 days (anticipated)
|
Image quality will be assessed by Likert score (1-5)
|
14 days (anticipated)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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 (Actual)
January 25, 2025
Primary Completion (Actual)
January 25, 2025
Study Completion (Actual)
March 25, 2025
Study Registration Dates
First Submitted
September 6, 2024
First Submitted That Met QC Criteria
September 6, 2024
First Posted (Actual)
September 19, 2024
Study Record Updates
Last Update Posted (Actual)
November 25, 2025
Last Update Submitted That Met QC Criteria
November 24, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 300079
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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