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New treatment option for Hemodialysis Access
Official title Single-Needle Distal Return for Long-Term Arteriovenous Fistula Care
ClinicalTrials.gov ID: NCT07372027
What this study is testing
- What it's testing
- Background: For millions of people worldwide with kidney failure, a well-functioning vascular access, like an arteriovenous fistula (AVF), is essential for life-sustaining hemodialysis. However, the standard method requires puncturing the same AVF with two needles three times a week, which over time can damage the vessel, leading to scarring, narrowing, and frequent failures.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Adult patients (age ≥ 18 years).
- Diagnosis of end-stage kidney disease (ESKD) requiring maintenance hemodialysis (three times per week).
- Reliable use of a native arteriovenous fistula (AVF) as the primary vascular access for at least the past 3 months.
- Willing and able to provide written informed consent to participate in the study.
- Adequate superficial venous vasculature in at least one lower extremity (e.g., dorsal foot veins, saphenous tributaries) as assessed by clinical...
You likely can't join if
- Active systemic infection or localized infection at the potential cannulation sites (AVF or lower extremity veins).
- Known severe coagulation disorder or thrombocytopenia (platelet count \< 50 × 10⁹/L) that would pose a high risk of bleeding complications from...
- Severe peripheral arterial disease or venous insufficiency in the lower extremities that contraindicates venous cannulation or may compromise limb...
- Unstable cardiovascular status (e.g., uncontrolled heart failure, severe arrhythmias) as determined by the treating nephrologist, which would...
- Documented severe cognitive impairment, psychiatric illness, or any condition that would impair the ability to provide informed consent or adhere to...
- Life expectancy less than 12 months due to non-renal comorbid conditions (e.g., metastatic malignancy).
See the full eligibility criteria
- Adult patients (age ≥ 18 years).
- Diagnosis of end-stage kidney disease (ESKD) requiring maintenance hemodialysis (three times per week).
- Reliable use of a native arteriovenous fistula (AVF) as the primary vascular access for at least the past 3 months.
- Willing and able to provide written informed consent to participate in the study.
- Adequate superficial venous vasculature in at least one lower extremity (e.g., dorsal foot veins, saphenous tributaries) as assessed by clinical evaluation and/or bedside ultrasound, deemed suitable for cannulation as a...
- For the experimental (SNDR) group: Expressed willingness to adopt the single-needle distal return cannulation strategy.
- For the control group: Currently receiving and willing to continue standard two-needle AVF cannulation.
- Active systemic infection or localized infection at the potential cannulation sites (AVF or lower extremity veins).
- Known severe coagulation disorder or thrombocytopenia (platelet count \< 50 × 10⁹/L) that would pose a high risk of bleeding complications from cannulation.
- Severe peripheral arterial disease or venous insufficiency in the lower extremities that contraindicates venous cannulation or may compromise limb perfusion.
- Unstable cardiovascular status (e.g., uncontrolled heart failure, severe arrhythmias) as determined by the treating nephrologist, which would increase the risk associated with any change in dialysis procedure.
- Documented severe cognitive impairment, psychiatric illness, or any condition that would impair the ability to provide informed consent or adhere to the study protocol.
- Life expectancy less than 12 months due to non-renal comorbid conditions (e.g., metastatic malignancy).
- Currently pregnant or breastfeeding.
- Participation in another treatment clinical trial that could confound the outcomes of this study.
- Anatomical or pathological condition of the AVF (e.g., extreme depth, aneurysm with overlying skin compromise, complete thrombosis) that precludes safe single-needle cannulation, as judged by the study vascular access...
- Inability to comply with the scheduled study visits and follow-up assessments.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.