Trials / Unknown
UnknownNCT05537779
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
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Guerbet · Industry
- Sex
- All
- Age
- 2 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CT examination | Administration of contrast medium using the power injector |
Timeline
- Start date
- 2022-10-01
- Primary completion
- 2022-12-01
- Completion
- 2023-01-01
- First posted
- 2022-09-13
- Last updated
- 2022-09-13
Source: ClinicalTrials.gov record NCT05537779. Inclusion in this directory is not an endorsement.