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

NCT05537779 | Unknown

• 1 other identifier: OPV-88-001
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patient Participation

Keywords

Safety; Performance; Power Injector; Optivantage

Outcome Measures

Primary Outcomes (2)

• Safety of Optivantage

  Rate of extravasation

  Per procedure

• Performance of Optivantage

  Success of injection

  Per procedure

Secondary Outcomes (2)

• Safety of Optivantage

  Per procedure

• Device deficiencies

  Per procedure

Interventions

CT examination DEVICE

Administration of contrast medium using the power injector

Eligibility Criteria

• Age: 2 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Subject referred for a contrast-enhanced CT examination using a power injector
• Subject or legal representative for children, having provided written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Guerbet: lead

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Jing Hao, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: September 13, 2022

Record last verified: 2022-09