CT 5400 RT System Application Clinical Study

November 24, 2025 updated by: Philips Clinical & Medical Affairs Global
The purpose of this study is to assess the satisfaction of the common functions, the operation convenience, and the whole system stability, and the safety of CT 5400 RT System.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

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

  • China
    • 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:

  • 18≤ Age ≤ 75 years old
  • Subjects with Clear consciousness; Subjects can cooperate and act autonomously
  • Subjects agree to participate in this clinical study and sign the subject's informed consent
  • Women subjects of childbearing age should have a negative pregnancy test and should have no plans to become pregnant in the next 6 months

Exclusion Criteria:

  • Subjects who do not have full capacity for civil conduct;
  • Women subjects who are pregnant or in lactating phase;
  • Subjects who have had a CT scan within one year;
  • Subjects with a history of allergies or asthma, severe hepatic and renal insufficiency or hyperthyroidism in which are considered as contraindication for CT contrast-enhanced examination;
  • According to the opinion of the investigator: any situation that may affect the evaluation of the results or expose subjects into health risk;
  • Subjects with mental disorders who cannot cooperate with the examination

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: Computed Tomography
Human subjects having CT scans
Radiation: Computed Tomography
X-ray by Computed Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the satisfaction of the common functions
Time Frame: 30 days (anticipated)
A three-scale assessment will be used for Image exposure level, couch movement, speaker& microphone voice quality, image post processing capability, data storage. A three-scale criteria- Very satisfied, Satisfied, Dissatisfied Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements.
30 days (anticipated)
the operation convenience assessment
Time Frame: 30 days (anticipated)
A three-scale assessment will be used for laser positioning, panel control, user-friendly interface of post-processing software, operation of post-processing software. A three-scale criteria- Very satisfied, Satisfied, Dissatisfied Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements.
30 days (anticipated)
the system stability assessment
Time Frame: 30 days (anticipated)
A three-scale assessment will be used for workflow, Image display and transmission, system inactivation, unexpected system shutdown, unexpected termination during scanning, fail to expose during scanning A three-scale criteria- Very satisfied, Satisfied, Dissatisfied Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements.
30 days (anticipated)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Clinical & Medical Affairs Global

Collaborators

Philips Healthcare (Suzhou) Co., Ltd.

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)

March 14, 2025

Primary Completion (Actual)

April 15, 2025

Study Completion (Actual)

April 18, 2025

Study Registration Dates

First Submitted

September 6, 2024

First Submitted That Met QC Criteria

September 11, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

December 2, 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

  • 300200

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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