Clin2
NCT07599085Possibly a fitNot yet recruiting

Single-needle dialysis access device safety and effectiveness study

Vascular Access

Part of Kidney & urinary clinical trials.

This study tests a new single-needle device (OnePoint Dialysis Cannula) for hemodialysis patients who currently use two needles. The goal is to see if one needle can work safely and effectively for patients with a healthy, mature vein (arteriovenous fistula or AVF).

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
20 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You are at least 18 years old and able to come to a dialysis center three times per week
  • You have a mature AVF (a surgically created vein connection for dialysis) that has been working well for at least 3 months with two needles
  • Your AVF meets specific size and flow requirements: blood flow of at least 500 mL/min, vein diameter of at least 5 mm, depth of 5 mm or less from your skin, and at least 5 cm of usable length
  • You have no narrowing (stenosis) or clots (thrombosis) in your AVF, confirmed by ultrasound
  • You have not had any active infections in the past 90 days and have not changed blood thinner medications in the past 60 days
  • Your dialysis center can collect data and monitor you closely for 30 days during the study

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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