Safety and Performance of Optivantage Multi-use When Injecting Contrast Media for Contrast Enhanced CT Examination
Not yet recruiting
- Conditions
- Patient Participation
- Registration Number
- NCT05537779
- Lead Sponsor
- Guerbet
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of Optivantage Per procedure Rate of extravasation
Performance of Optivantage Per procedure Success of injection
- Secondary Outcome Measures
Name Time Method Device deficiencies Per procedure Rate of device deficiencies including malfunction and error use
Safety of Optivantage Per procedure Rate of patient complications