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

Computed Tomography Clinical Trial

— PERCENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875469
• Other study ID #: 20521
• Status: Completed
• Phase: N/A
• Start date: June 21, 2019
• Est. completion date: March 10, 2020

Study information

• Verified date: March 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Computed Tomography

Intervention

Device:
• Centargo injector (BPI 1000045)
Contrast-enhanced computer tomography conducted with Centargo injector
• Stellant MP injector
Contrast-enhanced computer tomography conducted with Stellant MP injector

Locations

Country	Name	City	State
Australia	Medscan	Merrylands	New South Wales
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Australia,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Setup time of CT systems		1 day
Primary	Change time for bottle/ bag containing contrast medium		1 day
Primary	Patient setup time for the multi-patient set per day		1 day
Primary	Teardown time of CT-system		1 day
Primary	Number of multi-patient sets per day		1 day
Secondary	Total cost for multi-patients set and disposables per patient and day		1 day
Secondary	Reason for change of multi-patient syringe set for the injection of contrast media prior to expiration at 24 hours		1 day
Secondary	Volume of unused contrast agent at teardown time		1 day
Secondary	Volume of unused saline at teardown time		1 day
Secondary	Flow rate of contrast agent through the injector		1 day
Secondary	Volume of contrast agent delivered through injector		1 day
Secondary	Injector-generated pressure		1 day
Secondary	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
Secondary	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
Secondary	Number of errors requiring a CT-system reboot	For Centargo only (Part 2)	1 day

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