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

Patient Participation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05537779
• Other study ID #: OPV-88-001
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: January 2023

Study information

• Verified date: September 2022
• Source: Guerbet
• Contact: Jing Hao, MD
• Phone: +33 (0)1 45 91 51 76
• Email: jing.hao[@]guerbet.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Patient Participation

Intervention

Device:
• CT examination
Administration of contrast medium using the power injector

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Optivantage	Rate of extravasation	Per procedure
Primary	Performance of Optivantage	Success of injection	Per procedure
Secondary	Safety of Optivantage	Rate of patient complications	Per procedure
Secondary	Device deficiencies	Rate of device deficiencies including malfunction and error use	Per procedure