Computed Tomography Workflow AssessmentNCT06595888
CT 5400 RT System Application Clinical Study
A study testing Computed Tomography in people with Computed Tomography Workflow Assessment, run by Philips Clinical & Medical Affairs Global at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Computed Tomography Workflow Assessment
- What is being tested?
- Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2025to 18 Apr 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 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.
- Conditions
- Computed Tomography Workflow Assessment
- Being tested
- Computed Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyRadiation
X-ray by Computed Tomography
| Study group | Role | What they receive |
|---|---|---|
| Computed Tomography | Experimental | Human subjects having CT scans Receives: Radiation: Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
the satisfaction of the common functions
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: 30 days (anticipated)
the operation 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: 30 days (anticipated)
the system 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: 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 posted19 Sep 2024
- Study start14 Mar 2025
- Primary completion15 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computed Tomography Workflow AssessmentStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 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
- NCT06595888
- Sponsor's protocol ID
- 300200
- Status last verified
- Nov 2025
- First submitted
- 6 Sep 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT 5400 RT System Application Clinical Study
- ClinicalTrials.gov ID
- NCT06595888
- Acronym / sponsor ID
- 300200
- Conditions
- Computed Tomography Workflow Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Philips Healthcare (Suzhou) Co., Ltd.
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 19 Sep 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 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computed Tomography | Experimental | Radiation: Computed TomographyHuman subjects having CT scans |
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 |
|---|---|---|
| Computed TomographyX-ray by Computed Tomography | Radiation | Computed Tomography |
Primary outcome
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.
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.
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.
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 2 Dec 2025.
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 Computed Tomography in people with Computed Tomography Workflow Assessment, 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 2 Dec 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?
the satisfaction of the common functions (time frame: 30 days (anticipated)). The study lists 3 primary outcomes in all. 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 2 Dec 2025.