A Study of a Device That Helps Place Dialysis Needles

Condition(s) studied

Investigational drug(s) / intervention(s)

Needle placement with the Investigational Device: Dialysis cannulation needle placement with the investigational device

Needle Placement with SOC: Dialysis cannulation needle placement per SOC

Study summary

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).

Eligibility

Primary outcome measure(s)

• Cannulation Clinical Success Score (CCSS) — At each of six cannulation sessions over 2 weeks
  Co-primary endpoint. CCSS is achieved when haemodialysis is successfully started without additional needle puncture, needle repositioning or redirection, or infiltration. For each participant, the number of sessions achieving CCSS (out of three per treatment condition) is compared between the investigational device and standard of care (SOC). The study meets its primary effectiveness criterion only if both co-primary endpoints (CCSS and pain) are met.
• Mean Insertion Pain (0-10 Numeric Rating Scale) — At each of six cannulation sessions over 2 weeks
  Co-primary endpoint. Participants rate pain for each needle insertion on a 0-10 scale (0 = no pain, 10 = worst pain possible). Each participant's mean pain score with the investigational device is compared with their mean pain score with SOC. The study meets its primary effectiveness criterion only if both co-primary endpoints (CCSS and pain) are met.
• Rate of serious adverse events (SAEs) related to the investigational device or procedure during the clinical investigation. — At each of three investigational device cannulation sessions over 1 week
  Each participant will be a safety endpoint failure if the participant has SAEs related to the investigational device or procedure, otherwise the participant will be a primary safety endpoint success.

Trial sites (3)