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OpenTrials
Completed

NCT Number: NCT03875469

Study to Test the Usability of a New Injector to Administer Contrast Media Into Humans for Diagnostic Purposes

This study investigates if a new medical device, which injects contrast media and flushing solution into humans to increase the visibility of images taken of the human body for diagnostic purposes, is easier to handle, quicker and cheaper than an older injector.

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Key information

Conditions

Computed Tomography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medscan, Merrylands, New South Wales, Australia

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About this study

The study compares an investigational injection system (Centargo) for computed tomography (CT) to a currently marketed injection system (Stellant MP) in terms of efficiency, cost, performance and user satisfaction (Part 1). In addition, the reliability of the new injection system Centargo is tested (Part 2).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult subjects referred for contrast-enhanced computer tomography using a power injector

Exclusion criteria

  • Pregnant and lactating women
  • Subjects with know hypersensitivity to iodinated contrast media
  • Subjects with unacceptable renal function per local guidelines

Treatment and study plan

Centargo injector (BPI 1000045)

Device

Contrast-enhanced computer tomography conducted with Centargo injector

Stellant MP injector

Device

Contrast-enhanced computer tomography conducted with Stellant MP injector

Primary outcomes

  1. Setup time of CT systems

    Time frame: 1 day

  2. Change time for bottle/ bag containing contrast medium

    Time frame: 1 day

  3. Patient setup time for the multi-patient set per day

    Time frame: 1 day

  4. Teardown time of CT-system

    Time frame: 1 day

  5. Number of multi-patient sets per day

    Time frame: 1 day

Secondary outcomes

  1. Total cost for multi-patients set and disposables per patient and day

    Time frame: 1 day

  2. Reason for change of multi-patient syringe set for the injection of contrast media prior to expiration at 24 hours

    Time frame: 1 day

  3. Volume of unused contrast agent at teardown time

    Time frame: 1 day

  4. Volume of unused saline at teardown time

    Time frame: 1 day

  5. Flow rate of contrast agent through the injector

    Time frame: 1 day

  6. Volume of contrast agent delivered through injector

    Time frame: 1 day

  7. Injector-generated pressure

    Time frame: 1 day

  8. Number of automated system alerts

    Time frame: 1 day

    Incl. alerts due to communication loss, pressure limiting, air detection (Centargo only) and a full waste container (Centrago only).

  9. Radiographer satisfaction with contrast-media injector by study-related questionnaire

    Time frame: Up to 4.5 months

    Questionnaire contains 14 questions on injectors, disposables and software, pertaining to 5 levels of user satisfaction (´Very easy´ to ´Very hard´). Levels of user satisfaction from different questions are not combined.

  10. Number of errors requiring a CT-system reboot

    Time frame: 1 day

    For Centargo only (Part 2)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Performance of Centargo - A Novel Piston-based Injection System for High Throughput in Contrast-enhanced Computed Tomography (CE CT)

Acronym: PERCENT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 14, 2019
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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