Actively Recruiting
Guided Needle Insertion for Vascular Access
Led by X9, Inc. · Updated on 2026-04-23
10
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Guided Needle Insertion for Vascular Access
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or non-pregnant, non-breastfeeding females 18 years of age or older
- 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 12 mm, confirmed by ultrasound
- AVF is 6 mm or less 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Site 1
Tashkent, Uzbekistan
Actively Recruiting
Research Team
R
Rachel Walsh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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