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

Bayer

Status: Completed

Conditions: Computed Tomography

Treatments: Device: Centargo injector (BPI 1000045); Device: Stellant MP injector

Study type: Interventional

Funder types: Industry

Identifiers

NCT03875469

20521

Details and patient eligibility

About

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.

Full 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).

Enrollment: 425 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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425 participants in 3 patient groups

CT patients_Centargo_1

Experimental group

Description:

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

Treatment:

Device: Centargo injector (BPI 1000045)

CT-patients_Stellant_1

Experimental group

Description:

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

Treatment:

Device: Stellant MP injector

CT-patients_Centargo_2

Experimental group

Description:

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

Treatment:

Device: Centargo injector (BPI 1000045)