Spectral CT Clinical Trial

Study Overview
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Brief Summary
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The objective of this clinical trial was to evaluate the efficacy, ease of operation, stability, and safety of Spectral CT as expected.

Detailed Description
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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.

Official Title
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Spectral CT Clinical Trial

Conditions
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Adult ALL

Intervention / Treatment
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* Radiation: Spectral CT scanning


Participation Criteria
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Eligibility Criteria
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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.

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; | Radiation: Spectral CT scanning<br>* Volunteer accept spectral CT scanning<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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT scanning, image assessment