check_circleStudy Completed

Computed Tomography

Bayer Identifier:

20521

ClinicalTrials.gov Identifier:

NCT03875469

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to test the usability of a new injector to administer contrast media into humans for diagnostic purposes

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Adult subjects referred for contrast-enhanced computer tomography using a power injector

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

Trial summary

Enrollment Goal
425
Trial Dates
June 2019 - March 2020
Phase
N/A
Could I Receive a placebo
No
Products
BPI1000045
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
MedscanMerrylands, 2160, Australia
Completed
Maastricht University Medical CenterMaastricht, 6229, Netherlands

Primary Outcome

  • Setup time of CT systems
    date_rangeTime Frame:
    1 day
  • Change time for bottle/ bag containing contrast medium
    date_rangeTime Frame:
    1 day
  • Patient setup time for the multi-patient set per day
    date_rangeTime Frame:
    1 day
  • Teardown time of CT-system
    date_rangeTime Frame:
    1 day
  • Number of multi-patient sets per day
    date_rangeTime Frame:
    1 day

Secondary Outcome

  • Total cost for multi-patients set and disposables per patient and day
    date_rangeTime Frame:
    1 day
  • Reason for change of multi-patient syringe set for the injection of contrast media prior to expiration at 24 hours
    date_rangeTime Frame:
    1 day
  • Volume of unused contrast agent at teardown time
    date_rangeTime Frame:
    1 day
  • Volume of unused saline at teardown time
    date_rangeTime Frame:
    1 day
  • Flow rate of contrast agent through the injector
    date_rangeTime Frame:
    1 day
  • Volume of contrast agent delivered through injector
    date_rangeTime Frame:
    1 day
  • Injector-generated pressure
    date_rangeTime Frame:
    1 day
  • Number of automated system alerts
    Incl. alerts due to communication loss, pressure limiting, air detection (Centargo only) and a full waste container (Centrago only).
    date_rangeTime Frame:
    1 day
  • Radiographer satisfaction with contrast-media injector by study-related questionnaire
    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.
    date_rangeTime Frame:
    Up to 4.5 months
  • Number of errors requiring a CT-system reboot
    For Centargo only (Part 2)
    date_rangeTime Frame:
    1 day

Trial design

Performance of Centargo - A novel piston-based injection system for high throughput in contrast-enhanced computed tomography (CE CT)
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Diagnostic
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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