Computed Tomography Workflow Assessment
Conditions
Brief 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.
Interventions
RADIATIONComputed Tomography
X-ray by Computed Tomography
Sponsors
Philips Healthcare (Suzhou) Co., Ltd.
Philips Clinical & Medical Affairs Global
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
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 |
|---|---|---|
| the satisfaction of the common functions | 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 | 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 | 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. |
Countries
China
Outcome results
None listed