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)

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.

Study Overview

• Status: Completed
• Conditions: Computed Tomography
• Intervention / Treatment: Device: Centargo injector (BPI 1000045); Device: Stellant MP 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).

• Study Type: Interventional
• Enrollment (Actual): 425
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Merrylands, New South Wales, Australia, 2160
      • Medscan
• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT patients_Centargo_1; Adult patients referred for contrast-enhanced computed tomography in study part 1	Device: Centargo injector (BPI 1000045); Contrast-enhanced computer tomography conducted with Centargo injector
Experimental: CT-patients_Stellant_1; Adult patients referred for contrast-enhanced computed tomography in study part 1	Device: Stellant MP injector; Contrast-enhanced computer tomography conducted with Stellant MP injector
Experimental: CT-patients_Centargo_2; Adult patients referred for contrast-enhanced computed tomography in study part 2 (includes all patients of Arm 1)	Device: Centargo injector (BPI 1000045); Contrast-enhanced computer tomography conducted with Centargo injector

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Volume of contrast agent delivered through injector		1 day
Injector-generated pressure		1 day
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
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
Number of errors requiring a CT-system reboot	For Centargo only (Part 2)	1 day

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2019
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Contrast-enhanced computed tomography (CECT); Injector
• Other Study ID Numbers: 20521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD Plan Description

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No