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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-31

Study Completion Date

2023-01-31

Brief Summary

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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.

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Detailed Description

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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

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Patient Participation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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CT examination

Administration of contrast medium using the power injector

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No