A Study of a Device That Helps Place Dialysis Needles
The purpose of this study is to evaluate the safety and effectiveness of the X9 Ultrasound System with Power-Assisted Needle Insertion, an investigational device, compared with standard of care (SOC) cannulation for placing haemodialysis needles in an arteriovenous fistula (AVF) or arteriovenous graft (AVG).
Males or non-pregnant, non-breastfeeding females ≥ 21 years of age [+7]
Presence of known stents in the cannulation zone of the AVF/AVG access site [+1]