Performance and Safety
Conditions
Brief summary
The purpose of this clinical trial is to evaluate the efficacy and safety of the CT 5400 RT System.
Interventions
DIAGNOSTIC_TESTCT 5400 RT System
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.
Sponsors
Philips Healthcare (Suzhou) Co., Ltd.
Philips Clinical & Medical Affairs Global
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical image quality | 14 days (anticipated) | Image quality will be assessed by Likert score (1-5) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CT Scan-Emergent Adverse Events | 30 days (anticipated) | Monitor adverse events and serious adverse events(safety and tolerance) during the study |
| General function assessment | 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 | 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 | 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. |
Countries
China
Outcome results
None listed