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Investigational product had been released in NMPA, Sponsor decided to terminate the study aligned with investigator
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| Name | Class |
|---|---|
| Shanghai Changzheng Hospital | OTHER |
| Ruijin Hospital | OTHER |
| West China Hospital | OTHER |
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The purpose of this study was to evaluate the expected effectiveness, ease of operation, stability, and safety of Spectral CT
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group, all volunteer will be scanned. | Experimental | All participation accept Spectral CT scanning; No group; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectral CT | Device | Using Spectral CT to scan Breast |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of 1 year |
| Convenience evaluation assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiyuan Liu, Director | Shanghai Changzheng Hospital | Principal Investigator |
| Fuhua Yan, Director | Ruijin Hospital | Principal Investigator |
| Bin Song, Director | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Chengdu | Sichuan | China | |||
| Ruijin Hospital |
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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 |
| 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 | 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. | through study completion, an average of 1 year |
| Shanghai |
| China |
| Shanghai Changzheng Hospital | Shanghai | China |