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A Study of a Device That Helps Place Dialysis Needles
Sponsor: X9, Inc.
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).
Official title: Prospective Evaluation of Device-Assisted Needle Insertion for Vascular Access Study
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2026-12
Completion Date
2027-02
Last Updated
2026-10-02
Healthy Volunteers
No
Conditions
Interventions
Needle placement with the Investigational Device
Dialysis cannulation needle placement with the investigational device
Needle Placement with SOC
Dialysis cannulation needle placement per SOC
Locations (3)
Barwon Health
Geelong, Australia
St. Vincent's Hospital
Melbourne, Australia
Waikato Hospital
Hamilton, New Zealand