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Recruiting Not applicable NCT07548151

Guided Needle Insertion for Vascular Access

No applicable phase (e.g. observational)
Conditions: End Stage Renal Failure, Hemodialysis Cannulation

Sponsor: X9, Inc.

trial.available_in: БГ
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?
Who can participate
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
Interventions
Ultrasound-Guided, Power-Assisted Needle Insertion
DEVICE
Locations 1
Uzbekistan (1)
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.05.2026
Registry ID
NCT07548151
Source
clinicaltrials.gov
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