The study is a prospective, single-arm observational multicenter clinical investigation. The primary objective is to confirm the safety and performance of the Optivantage® Injection System when injecting contrast media to subjects requiring contrast-enhanced CT imaging, in multi-patient use.
Each subject will undergo CT examination in multi-use context using Optivantage Dual-head Contrast Delivery System. 100 subjects are expected to be enrolled. The safety and performance of the injector will be evaluated.
Study Type
OBSERVATIONAL
Enrollment
100
Administration of contrast medium using the power injector
Safety of Optivantage
Rate of extravasation
Time frame: Per procedure
Performance of Optivantage
Success of injection
Time frame: Per procedure
Safety of Optivantage
Rate of patient complications
Time frame: Per procedure
Device deficiencies
Rate of device deficiencies including malfunction and error use
Time frame: Per procedure
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