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NCT07856095
A Study of a Device That Helps Place Dialysis Needles
Conditions: Dialysis, Cannulation, Vascular Access
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 35
Sponsor: X9, Inc.
Location: Barwon Health Geelong
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 Criteria
Inclusion Criteria:
1. Males or non-pregnant, non-breastfeeding females ≥ 21 years of age
2. Receiving facility-based (in-center) haemodialysis
3. Presence of an arteriovenous fistula (AVF) or arteriovenous graft (AVG) in the arm.
4. AVF/AVG is actively used for haemodialysis treatment.
5. AVF/AVG diameter between 6 mm and 12 mm, confirmed by ultrasound.
6. AVF/AVG is ≤6 mm below the surface of the skin, confirmed by ultrasound.
7. Able to complete the study questionnaires.
8. Able and willing to provide written informed consent.
Exclusion Criteria:
1. Presence of known stents in the cannulation zone of the AVF/AVG access site
2. Presence of a condition or impediment that may interfere with ultrasound imaging
Source: ClinicalTrials.gov (NCT07856095). StuddyBuddy aggregates publicly available trial information.
