Performance of Centargo: A Novel Piston-Based Injection System for High Throughput in CE CT * The PerCenT Study

Completed

• Conditions: Adult patients referred for contrast-enhanced Computed Tomography; CT scan

• Registration Number: NL-OMON48114
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 525

Inclusion Criteria

- Adult subjects (* 18 years) referred for contrast-enhanced Computed Tomography
- Adult subjects capable of providing informed consent.

Exclusion Criteria

- Pregnant and lactating women
- Children (< 18 years)
- Subjects with known hypersensitivity to iodinated contrast media
- Subjects with unacceptable renal function per local guidelines

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is improved workflow efficiency via lower<br /><br>setup times and improved usability of Centargo vs Stellant MP. To measure time<br /><br>savings, setup time for the multi-patient set (MPDS for Stellant MP, Day Set<br /><br>for Centargo), change time for bottle/bag, patient setup time (SPDS for<br /><br>Stellant MP, Patient Line for Centargo), and teardown time for the MP set will<br /><br>be collected. The number of multi-patient sets used per day will also be<br /><br>recorded, allowing for calculation of the total amount of interaction time per<br /><br>day for each injector system.<br /><br><br /><br>No patient outcomes will be measured. Injection system Performance measures as<br /><br>described above.</p><br>