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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT patients_Centargo_1 | Experimental | Adult patients referred for contrast-enhanced computed tomography in study part 1 |
|
| CT-patients_Stellant_1 | Experimental | Adult patients referred for contrast-enhanced computed tomography in study part 1 |
|
| CT-patients_Centargo_2 | Experimental | Adult patients referred for contrast-enhanced computed tomography in study part 2 (includes all patients of Arm 1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Centargo injector (BPI 1000045) | Device | Contrast-enhanced computer tomography conducted with Centargo injector |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medscan | Merrylands | New South Wales | 2160 | Australia | ||
| Maastricht University Medical Center |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| Stellant MP injector | Device | Contrast-enhanced computer tomography conducted with Stellant MP injector |
|
| 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 | Incl. alerts due to communication loss, pressure limiting, air detection (Centargo only) and a full waste container (Centrago only). | 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. | Up to 4.5 months |
| Number of errors requiring a CT-system reboot | For Centargo only (Part 2) | 1 day |
| Maastricht |
| Limburg |
| 6229 |
| Netherlands |