Clinical Study of CT 5400 RT for Precise Image Validation | NCT06589934

Studies
Clinical Study of CT 5400 RT for Precise Image Validation

NCT06589934

Sponsor

Philips Clinical & Medical Affairs Global

Status

Completed

Last Update Posted

Nov 25, 2025Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Precise Image (AI Reconstruction Feature of CT 5400 RT System)

Interventions

Precise Image

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2025Actual

Primary Completion Date

Jan 25, 2025Actual

Completion Date

Mar 25, 2025Actual

First Submitted Date

Sep 6, 2024

First Submission Date that Met QC Criteria

Sep 6, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2025

Last Update Posted Date

Nov 25, 2025Actual

Name	Class
Philips Healthcare (Suzhou) Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Image quality	Experimental	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)	Diagnostic Test: Precise Image

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Precise Image	Diagnostic Test	Image reconstruction software	Image quality

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Public Health Clinical Center		Shanghai	Shanghai Municipality	200120	China