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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Participation
• Intervention / Treatment: Device: CT examination

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jing Hao, MD; Phone Number: +33 (0)1 45 91 51 76; Email: jing.hao@guerbet.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects referred for contrast enhanced CT examination who meet the eligibility criteria

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guerbet

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Performance; Power Injector; Optivantage
• Other Study ID Numbers: OPV-88-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No