Cannulation, End Stage Renal Failure, Hemodialysis
Conditions
Keywords
Vascular access, hemodialysis, cannulation
Brief summary
The goal of this clinical trial is to determine whether the study device can assist the cannulator with placing two needles during cannulation required to initiate dialysis treatment. Males or females with end-stage kidney disease who are 18 and older and not pregnant or breastfeeding can be included in the study. The main question it aims to answer is: Can the study device guide the cannulator to the arteriovenous fistula (AVF) or arteriovenous graft (AVG) and assist the cannulator with needle insertion into the AVF or AVG for dialysis cannulation?
Interventions
DEVICEUltrasound-Guided, Power-Assisted Needle Insertion
Device Intervention
Sponsors
X9, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Participant serves as their own control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or non-pregnant, non-breastfeeding females ≥ 18 years of age * Presence of an AVG/AVF access site in the forearm or upper arm * AVF is actively used for dialysis treatment * AVF diameter is between 8 mm and 12mm, confirmed by ultrasound * AVF is ≤6 mm below the surface of the skin, confirmed by ultrasound * Able to report their pain using a validated pain scale. * Able and willing to provide written informed consent.
Exclusion criteria
* Presence of known (pseudo-)aneurysms, stenosis, thrombosis or stents in the AVF/AVG access site * Presence of a condition or impediment that may interfere with ultrasound imaging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of investigational device cannulations in which successful cannulation of the AVF/AVG is achieved within a maximum of three attempts, confirmed by blood flashback and ability to proceed with dialysis. | 1 week |
Countries
Uzbekistan
Outcome results
None listed