Clinical Study of CT 5400 RT for System… | Clinical Trial

Key information

Conditions

Performance and Safety

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 200120, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT 5400 RT System

Diagnostic Test

Computed Tomography X-RAY System is intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Primary outcomes

Clinical image quality

Time frame: 14 days (anticipated)

Image quality will be assessed by Likert score (1-5)

Secondary outcomes

General function assessment

Time frame: 14 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.
Convenience assessment

Time frame: 14 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.
Workflow and stability assessment

Time frame: 14 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.
Incidence of CT Scan-Emergent Adverse Events

Time frame: 30 days (anticipated)

Monitor adverse events and serious adverse events(safety and tolerance) during the study

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Collaborators

Philips Healthcare (Suzhou) Co., Ltd.

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jun 20, 2024
Registry last updated: Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.