Computed Tomography
Conditions
Keywords
Contrast-enhanced computed tomography (CECT), Injector
Brief summary
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.
Detailed description
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).
Interventions
DEVICECentargo injector (BPI 1000045)
Contrast-enhanced computer tomography conducted with Centargo injector
DEVICEStellant MP injector
Contrast-enhanced computer tomography conducted with Stellant MP injector
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Setup time of CT systems | 1 day |
| Change time for bottle/ bag containing contrast medium | 1 day |
| Patient setup time for the multi-patient set per day | 1 day |
| Teardown time of CT-system | 1 day |
| Number of multi-patient sets per day | 1 day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total cost for multi-patients set and disposables per patient and day | 1 day | — |
| Reason for change of multi-patient syringe set for the injection of contrast media prior to expiration at 24 hours | 1 day | — |
| Volume of unused contrast agent at teardown time | 1 day | — |
| Volume of unused saline at teardown time | 1 day | — |
| Flow rate of contrast agent through the injector | 1 day | — |
| Volume of contrast agent delivered through injector | 1 day | — |
| Injector-generated pressure | 1 day | — |
| Number of automated system alerts | 1 day | Incl. alerts due to communication loss, pressure limiting, air detection (Centargo only) and a full waste container (Centrago only). |
| Radiographer satisfaction with contrast-media injector by study-related questionnaire | 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. |
| Number of errors requiring a CT-system reboot | 1 day | For Centargo only (Part 2) |
Countries
Australia, Netherlands
Outcome results
None listed