Adult ALL
Conditions
Keywords
CT scanning, image assessment
Brief summary
The objective of this clinical trial was to evaluate the efficacy, ease of operation, stability, and safety of Spectral CT as expected.
Detailed description
Under the premise of protecting subjects and ensuring the scientific nature of this clinical trial, Spectral CT was evaluated for its effectiveness, convenience, stability and safety under normal conditions by collecting clinical cases.
Interventions
RADIATIONSpectral CT scanning
Volunteer accept spectral CT scanning
Sponsors
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
* Volunteers (ages 18 to 75); * Negative pregnancy tests for women of childbearing age; * Agree to participate in the clinical trial and sign the subject informed consent form; * Enhanced scan requires laboratory evidence of normal renal function.
Exclusion criteria
* The body cannot comply with CT examination; * Pregnant and lactating women; * Claustrophobia; * People who are not suitable for enhanced scanning with iodine contrast agent (previous severe heart failure and hyperthyroidism, iodine contrast agent allergy and susceptibility); * Patients deemed unsuitable for participation in this clinical trial by the investigator.
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