CT Scanning
Conditions
Brief summary
The purpose of this study was to evaluate the expected effectiveness, ease of operation, stability, and safety of Spectral CT
Detailed description
Under the premise of protecting subjects and ensuring the scientific nature of this study, Spectral CT was evaluated for its effectiveness, convenience, stability and safety under normal conditions by collecting clinical cases.
Interventions
DEVICESpectral CT
Using Spectral CT to scan Breast
Sponsors
Shanghai Changzheng Hospital
Ruijin Hospital
West China Hospital
Philips (China) Investment CO., LTD
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
* Recruit volunteers (ages 18 to 75); * Negative pregnancy tests in women of childbearing age; * Participants who agree to participate in this clinical trial and sign the informed consent; * Enhanced scans require laboratory tests to confirm normal renal function.
Exclusion criteria
* Persons who do not have full capacity for civil conduct; * Lactating women; * People who are not suitable for enhanced scanning with iodine contrast agent; * Patients whom the investigator considers inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excellent and good rate of clinical imaging (score≥3） | through study completion, an average of 1 year | Rated items 5 points Excellent image quality for diagnostic purposes, very satisfactory 4 points good image quality, can be used for diagnosis, satisfactory 3 points Image quality defects, do not affect the diagnosis, general 2. Unsatisfactory image quality, affecting diagnosis Poor image quality, undiagnosable, unsatisfactory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Common functions assessment | through study completion, an average of 1 year | Common function evaluation items inclduing:The exposure function; Bed body moving; Microphone intercom function; Image post-processing function; Data storage management. With Satisfied, normal, Not Satisfied |
| Convenience evaluation assessment | through study completion, an average of 1 year | Convenience function evaluation items inclduing:Laser positioning lamp Breathing navigation Control buttons The clinical interface friendliness of postprocessing software The post-processing software is convenient for clinical use and operation. With Satisfied, normal, Not Satisfied |
| Machine function and stability assessment | through study completion, an average of 1 year | Machine function and stability evaluation items inclduing:workflow Image display and transmission Failed to start system Unexpected system shutdown Abnormal termination during the scan Unable to expose during scan. With Satisfied, normal, Not Satisfied |
| Adverse events and serious adverse events | through study completion, an average of 1 year | Adverse events and serious adverse events during the test were collected to evaluate the safety of the product. |
Countries
China
Outcome results
None listed