RecruitingNot ApplicableNCT07548151

Guided Needle Insertion for Vascular Access

Ultrasound-Guided Power-Assisted Needle Insertion for Vascular Access Study

Sponsor

X9, Inc.

Enrollment

10 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Cannulation End Stage Renal Failure, Hemodialysis

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?

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria2

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

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