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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Computed Tomography

Intervention / Treatment
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* Device: Centargo injector (BPI 1000045)
* Device: Stellant MP injector


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT patients_Centargo_1<br>Adult patients referred for contrast-enhanced computed tomography in study part 1 | Device: Centargo injector (BPI 1000045)<br>* Contrast-enhanced computer tomography conducted with Centargo injector<br>|
| Experimental: CT-patients_Stellant_1<br>Adult patients referred for contrast-enhanced computed tomography in study part 1 | Device: Stellant MP injector<br>* Contrast-enhanced computer tomography conducted with Stellant MP injector<br>|
| Experimental: CT-patients_Centargo_2<br>Adult patients referred for contrast-enhanced computed tomography in study part 2 (includes all patients of Arm 1) | Device: Centargo injector (BPI 1000045)<br>* Contrast-enhanced computer tomography conducted with Centargo injector<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast-enhanced computed tomography (CECT), Injector