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

NCT ID: NCT03875469

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-21

Study Completion Date

2020-03-10

Brief Summary

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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

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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).

Conditions

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Computed Tomography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CT patients_Centargo_1

Adult patients referred for contrast-enhanced computed tomography in study part 1

Group Type EXPERIMENTAL

Centargo injector (BPI 1000045)

Intervention Type DEVICE

Contrast-enhanced computer tomography conducted with Centargo injector

CT-patients_Stellant_1

Adult patients referred for contrast-enhanced computed tomography in study part 1

Group Type EXPERIMENTAL

Stellant MP injector

Intervention Type DEVICE

Contrast-enhanced computer tomography conducted with Stellant MP injector

CT-patients_Centargo_2

Adult patients referred for contrast-enhanced computed tomography in study part 2 (includes all patients of Arm 1)

Group Type EXPERIMENTAL

Centargo injector (BPI 1000045)

Intervention Type DEVICE

Contrast-enhanced computer tomography conducted with Centargo injector

Interventions

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Centargo injector (BPI 1000045)

Contrast-enhanced computer tomography conducted with Centargo injector

Intervention Type DEVICE

Stellant MP injector

Contrast-enhanced computer tomography conducted with Stellant MP injector

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medscan

Merrylands, New South Wales, Australia

Site Status

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status

Countries

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Australia Netherlands

Related Links

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http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

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20521

Identifier Type: -

Identifier Source: org_study_id

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