Ultrasound-guided power-assisted needle insertion for vascular access
Patients undergoing dialysis for end stage renal disease.
Each participant will have the study device used once during a single dialysis session. The device assists the dialysis nurse or technician in inserting one of the dialysis needles by identifying the location of the vascular access (fistula) and providing ultrasound and AI-based localization guidance to deliver accurate needle placement for dialysis cannulation. The duration of exposure to the device is expected to be brief, lasting approximately one to three minutes.
1. Males or non-pregnant, non-breastfeeding females ≥ 18 years of age 2. Presence of an upper extremity arteriovenous fistula (AVF) access site in the forearm or upper arm 3. AVF is actively used for dialysis treatment 4. AVF diameter is between 8 mm and 12mm, confirmed by ultrasound 5. AVF is ≤6 mm below the surface of the skin, confirmed by ultrasound 6. Able to understand and complete a pain questionnaire 7. Able and willing to provide written informed consent
1. Arteriovenous graft (AVG) is actively used for dialysis treatment. 2. Presence of known (pseudo-)aneurysms, stenosis, thrombosis or stents in the AVF access site 3. Presence of a condition or impediment that may interfere with ultrasound imaging