check_circleStudy Completed
Computed Tomography
Bayer Identifier:
20521
ClinicalTrials.gov Identifier:
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
AllAge
18 - N/ATrial summary
Enrollment Goal
425Trial Dates
June 2019 - March 2020Phase
N/ACould I Receive a placebo
NoProducts
BPI1000045Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Medscan | Merrylands, 2160, Australia |
Completed | Maastricht University Medical Center | Maastricht, 6229, Netherlands |
Primary Outcome
- Setup time of CT systemsdate_rangeTime Frame:1 day
- Change time for bottle/ bag containing contrast mediumdate_rangeTime Frame:1 day
- Patient setup time for the multi-patient set per daydate_rangeTime Frame:1 day
- Teardown time of CT-systemdate_rangeTime Frame:1 day
- Number of multi-patient sets per daydate_rangeTime Frame:1 day
Secondary Outcome
- Total cost for multi-patients set and disposables per patient and daydate_rangeTime Frame:1 day
- Reason for change of multi-patient syringe set for the injection of contrast media prior to expiration at 24 hoursdate_rangeTime Frame:1 day
- Volume of unused contrast agent at teardown timedate_rangeTime Frame:1 day
- Volume of unused saline at teardown timedate_rangeTime Frame:1 day
- Flow rate of contrast agent through the injectordate_rangeTime Frame:1 day
- Volume of contrast agent delivered through injectordate_rangeTime Frame:1 day
- Injector-generated pressuredate_rangeTime Frame: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).date_rangeTime Frame: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.date_rangeTime Frame:Up to 4.5 months
- Number of errors requiring a CT-system rebootFor Centargo only (Part 2)date_rangeTime Frame:1 day
Trial design
Trial Type
InterventionalIntervention Type
DeviceTrial Purpose
DiagnosticAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3