Trial Condition(s):
Computed Tomography
Study to test the usability of a new injector to administer contrast media into humans for diagnostic purposes (PERCENT)
Bayer Identifier:
20521
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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 guidelinesTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Medscan Merrylands, Australia, 2160 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Maastricht University Medical Center Maastricht, Netherlands, 6229 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
Primary Outcome
- Setup time of CT systemsTimeframe: 1 day
- Change time for bottle/ bag containing contrast mediumTimeframe: 1 day
- Patient setup time for the multi-patient set per dayTimeframe: 1 day
- Teardown time of CT-systemTimeframe: 1 day
- Number of multi-patient sets per dayTimeframe: 1 day
Secondary Outcome
- Total cost for multi-patients set and disposables per patient and dayTimeframe: 1 day
- Reason for change of multi-patient syringe set for the injection of contrast media prior to expiration at 24 hoursTimeframe: 1 day
- Volume of unused contrast agent at teardown timeTimeframe: 1 day
- Volume of unused saline at teardown timeTimeframe: 1 day
- Flow rate of contrast agent through the injectorTimeframe: 1 day
- Volume of contrast agent delivered through injectorTimeframe: 1 day
- Injector-generated pressureTimeframe: 1 day
- Number of automated system alertsIncl. alerts due to communication loss, pressure limiting, air detection (Centargo only) and a full waste container (Centrago only).Timeframe: 1 day
- Radiographer satisfaction with contrast-media injector by study-related questionnaireQuestionnaire 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.Timeframe: Up to 4.5 months
- Number of errors requiring a CT-system rebootFor Centargo only (Part 2)Timeframe: 1 day
Additional Information
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