Performance and SafetyNCT06466577
Clinical Study of CT 5400 RT for System Validation
A study testing CT 5400 RT System in people with Performance and Safety, run by Philips Clinical & Medical Affairs Global at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the efficacy and safety of the CT 5400 RT System. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance and Safety
- What is being tested?
- CT 5400 RT System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2025to 20 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 200120
About this study
The purpose of this clinical trial is to evaluate the efficacy and safety of the CT 5400 RT System.
- Conditions
- Performance and Safety
- Being tested
- CT 5400 RT System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT 5400 RT SystemDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Image quality performance | Other | Not described Receives: Diagnostic Test: CT 5400 RT System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical image quality
Image quality will be assessed by Likert score (1-5)
Measured: 14 days (anticipated)
Secondary outcomes (4)
General function assessment
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.
Measured: 14 days (anticipated)
Convenience assessment
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.
Measured: 14 days (anticipated)
Workflow and stability assessment
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.
Measured: 14 days (anticipated)
Incidence of CT Scan-Emergent Adverse Events
Monitor adverse events and serious adverse events(safety and tolerance) during the study
Measured: 30 days (anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start17 Jan 2025
- Primary completion25 Jan 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance and SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Philips Healthcare (Suzhou) Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466577
- Sponsor's protocol ID
- 200254
- Status last verified
- Jun 2025
- First submitted
- 9 Apr 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CT 5400 RT for System Validation
- ClinicalTrials.gov ID
- NCT06466577
- Acronym / sponsor ID
- 200254
- Conditions
- Performance and Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Philips Healthcare (Suzhou) Co., Ltd.
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to evaluate the efficacy and safety of the CT 5400 RT System.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Image quality performance | Other | Diagnostic Test: CT 5400 RT System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT 5400 RT SystemComputed 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. | Diagnostic test | Image quality performance |
Primary outcome
Clinical image quality
Time frame: 14 days (anticipated)
Image quality will be assessed by Likert score (1-5)
4 secondary outcomes
General function assessment
Time frame: 14 days (anticipated)
Convenience assessment
Time frame: 14 days (anticipated)
Workflow and stability assessment
Time frame: 14 days (anticipated)
Incidence of CT Scan-Emergent Adverse Events
Time frame: 30 days (anticipated)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT 5400 RT System in people with Performance and Safety, run by Philips Clinical & Medical Affairs Global at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical image quality (time frame: 14 days (anticipated)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.