The objective of this clinical trial was to evaluate the efficacy, ease of operation, stability, and safety of Spectral CT as expected.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
56
Volunteer accept spectral CT scanning
Peking Union Medical College Hospital
Beijing, China
Nanfang Hospital
Guangzhou, China
The First Hospital of Xian Jiaotong University
Xi'an, China
Excellent and good rate of clinical imaging (score≥3）
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
Time frame: through study completion, an average of 1 year
Common functions assessment
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
Time frame: through study completion, an average of 1 year
Convenience evaluation assessment
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
Time frame: through study completion, an average of 1 year
Machine function and stability assessment
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
Time frame: through study completion, an average of 1 year
Adverse events and serious adverse events
Adverse events and serious adverse events during the test were collected to evaluate the safety of the product.
Time frame: through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.