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

Not Applicable

Completed

• Conditions: Computed Tomography
• Interventions: Device: Stellant MP injector; Device: Centargo injector (BPI 1000045)

• Registration Number: NCT03875469
• Lead Sponsor: Bayer

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.

Detailed 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Study Start: 2019-06-21
• Primary Completion: 2020-03-10
• Study Completion: 2020-03-10
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

Inclusion Criteria

• Adult subjects referred for contrast-enhanced computer tomography using a power injector

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Exclusion Criteria

• Pregnant and lactating women
• Subjects with know hypersensitivity to iodinated contrast media
• Subjects with unacceptable renal function per local guidelines

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-patients_Stellant_1	Stellant MP injector	Adult patients referred for contrast-enhanced computed tomography in study part 1
CT patients_Centargo_1	Centargo injector (BPI 1000045)	Adult patients referred for contrast-enhanced computed tomography in study part 1
CT-patients_Centargo_2	Centargo injector (BPI 1000045)	Adult patients referred for contrast-enhanced computed tomography in study part 2 (includes all patients of Arm 1)

Primary Outcome Measures

Name	Time	Method
Setup time of CT systems	1 day
Change time for bottle/ bag containing contrast medium	1 day
Number of multi-patient sets per day	1 day
Teardown time of CT-system	1 day
Patient setup time for the multi-patient set per day	1 day

Secondary Outcome Measures

Name	Time	Method
Total cost for multi-patients set and disposables per patient and day	1 day
Volume of unused saline at teardown time	1 day
Volume of contrast agent delivered through injector	1 day
Injector-generated pressure	1 day
Number of errors requiring a CT-system reboot	1 day	For Centargo only (Part 2)
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
Number of automated system alerts	1 day	Incl. alerts due to communication loss, pressure limiting, air detection (Centargo only) and a full waste container (Centrago only).
Radiographer satisfaction with contrast-media injector by study-related questionnaire	Up to 4.5 months	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.
Flow rate of contrast agent through the injector	1 day

Trial Locations

Locations (2)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands

Medscan; 🇦🇺 Merrylands, New South Wales, Australia