Guided Needle Insertion for Vascular Access

X9, Inc.10 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

End Stage Renal Failure, Hemodialysis Cannulation

Interventions

Ultrasound-Guided, Power-Assisted Needle InsertionDEVICE

Device Intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Site 1

Tashkent, Uzbekistan

Outcomes

Primary Outcomes

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.

Time frame: 1 week

Data from ClinicalTrials.gov

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