Spectral CT Clinical Trial Protocol

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the expected effectiveness, ease of operation, stability, and safety of Spectral CT

Detailed Description
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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.

Official Title
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Spectral CT Clinical Trial Protocol

Conditions
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CT Scanning

Intervention / Treatment
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* Device: Spectral CT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group, all volunteer will be scanned.<br>All participation accept Spectral CT scanning; No group; | Device: Spectral CT<br>* Using Spectral CT to scan Breast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |