Study to Test the Usability of a New Injector to Administer Contrast Media Into Humans for Diagnostic Purposes
PERCENT
Performance of Centargo - A Novel Piston-based Injection System for High Throughput in Contrast-enhanced Computed Tomography (CE CT)
1 other identifier
interventional
425
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2019
CompletedFirst Posted
Study publicly available on registry
March 14, 2019
CompletedStudy Start
First participant enrolled
June 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2020
CompletedMarch 3, 2021
March 1, 2021
9 months
February 26, 2019
March 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (3)
CT patients_Centargo_1
EXPERIMENTALAdult patients referred for contrast-enhanced computed tomography in study part 1
CT-patients_Stellant_1
EXPERIMENTALAdult patients referred for contrast-enhanced computed tomography in study part 1
CT-patients_Centargo_2
EXPERIMENTALAdult patients referred for contrast-enhanced computed tomography in study part 2 (includes all patients of Arm 1)
Interventions
Contrast-enhanced computer tomography conducted with Centargo injector
Contrast-enhanced computer tomography conducted with Stellant MP injector
Eligibility Criteria
You may qualify if:
- Adult subjects referred for contrast-enhanced computer tomography using a power injector
You may not qualify if:
- Pregnant and lactating women
- Subjects with know hypersensitivity to iodinated contrast media
- Subjects with unacceptable renal function per local guidelines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (2)
Medscan
Merrylands, New South Wales, 2160, Australia
Maastricht University Medical Center
Maastricht, Limburg, 6229, Netherlands
Related Links
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2019
First Posted
March 14, 2019
Study Start
June 21, 2019
Primary Completion
March 10, 2020
Study Completion
March 10, 2020
Last Updated
March 3, 2021
Record last verified: 2021-03