Safety and Performance of Optivantage Multi-use When Injecting Contrast Media for Contrast Enhanced CT Examination

Safety and Performance of Optivantage Multi-use Solution When Injecting Contrast Media to Subjects Requiring Contrast Enhanced CT Examination

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.

Inclusion Criteria:

• Subject referred for a contrast-enhanced CT examination using a power injector
• Subject or legal representative for children, having provided written informed consent

Exclusion Criteria:

• Subject weighting less than 10 kg
• Pregnant or breastfeading woman subject
• Subject with known allergy or hypersensitivity to contrast media
• Subject has contra-indication(s) to CT scanner and/or contrast medium as per the Summary of Product Characteristics
• Subject with peripherally inserted central catheter, central venous line, or port-A-catheter inserted for injection
• Subject unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood of completing the study