Spectral CT Clinical Trial Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 51
- Locations
- 3
- Primary Endpoint
- Excellent and good rate of clinical imaging (score≥3）
Study Overview
Brief Summary
The purpose of this study was to evaluate the expected effectiveness, ease of operation, stability, and safety of Spectral CT
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Experimental group, all volunteer will be scanned.
All participation accept Spectral CT scanning; No group;
Intervention: Spectral CT (Device)
Outcomes
Primary Outcomes
Excellent and good rate of clinical imaging (score≥3）
Time Frame: 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 Outcomes
- Common functions assessment(through study completion, an average of 1 year)
- Convenience evaluation assessment(through study completion, an average of 1 year)
- Machine function and stability assessment(through study completion, an average of 1 year)
- Adverse events and serious adverse events(through study completion, an average of 1 year)