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

To compare an investigational device (MEDRAD^® Centargo CT Injection System, "Centargo") to the currently available MEDRAD^® Stellant CT Injection System ("Stellant"), in terms of efficiency, injector performance, and user satisfaction.

A total of 425 patients at two sites were enrolled; 198 patients in phase one, a randomized study (98 Stellant and 100 Centargo). The second observational phase included 227 patients who were injected with Centargo. Phase one recorded times for setup, disassembly, and patient changeovers. Demographic data, subjective image quality, and injection parameters were collected. Phase two assessed usability via a questionnaire provided to all end-users of both systems (radiographers).

Patient changeover times were statistically significantly faster with Centargo (15.4s ± 8.7s vs 53.7s ± 19.6s, p < 0.001). Centargo day-setup times were similar to Stellant (138.1s ± 92s vs 151.8s ± 30.6s, p = 0.33) and end-of-day-disassembly times were significantly slower (60.6s ± 27s vs 17.1s ± 12.9s, p < 0.001). Based on four different scenarios modelling patient throughput, the projected time savings with Centargo over Stellant was 40-63%, with the highest efficiency improvements for higher throughputs and the use of larger contrast medium bottles. Both Centargo and Stellant usability averaged between "Very Easy" and "Easy" in all responses to the questionnaire. There were no instances of interrupted injections due to communication loss or detected air and no insufficient images due to injector performance. No safety issues were identified.

Centargo was able to demonstrate improved efficiency as compared to Stellant while maintaining injector performance and high usability scores.