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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05537779

Enrollment

100

Registered

2022-09-13

Start date

2022-10-31

Completion date

2023-01-31

Last updated

2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Participation

Keywords

Safety, Performance, Power Injector, Optivantage

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.

Interventions

DEVICECT examination

Administration of contrast medium using the power injector

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety of Optivantage	Per procedure	Rate of extravasation
Performance of Optivantage	Per procedure	Success of injection

Secondary

Measure	Time frame	Description
Safety of Optivantage	Per procedure	Rate of patient complications
Device deficiencies	Per procedure	Rate of device deficiencies including malfunction and error use

Contacts

Primary ContactJing Hao, MD

jing.hao@guerbet.com+33 (0)1 45 91 51 76

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026