How the bevel orientation of AVF punctures affects hemodialysis needle insertions
Official title: Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis: A Multicenter Randomized Comparative Study
Run by Centre Hospitalier Emile Roux · NCT06708338 · Data updated 2026-11-12
This study tests whether adjusting the bevel direction of the dialysis needle improves puncture success for people with a native arteriovenous fistula needing regular hemodialysis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Centre Hospitalier Emile Roux Academic / other |
| Locations | 4 sites (Le Puy-en-Velay and 3 other locations) |
| Status | Recruiting |
| Started | January 7, 2026 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2029 |
| Registry record updated | August 4, 2026 |
| Trial ID | NCT06708338 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a single, mature native upper-limb AVF requiring regular thrice-weekly hemodialysis, and no prior puncture of that AVF.
✕Probably not a fit
Patients with non-native access, prior AVF punctures, or alternative dialysis access are less likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study investigates whether the angle of the needle bevel during AVF punctures influences puncture success and potentially reduces complications in adults with native AVFs undergoing standard four-hour, thrice-weekly hemodialysis. Eligible participants have a mature, first AVF in the upper limb, with a history of at least one year of anticipated dialysis, and meet other clinical criteria. The trial will compare different needle bevel orientations during double-needle dialysis sessions conducted at participating centers. Outcomes will inform best practices for AVF puncture technique and may impact routine hemodialysis care.
Why it matters
Potential benefit: If successful, the bevel orientation may improve puncture reliability and patient comfort during dialysis sessions.
How similar studies have gone: Prior research on AVF puncture techniques has shown variability; this study explores a specific mechanical variable (bevel orientation) with potential for clear practice implications.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * male or female with Chronic Kidney Disease * patient requiring 4-hour hemodialysis sessions, 3 times per week, in a dialysis center * Native arteriovenous fistula (AVF) (without prosthesis), mature, with no prior puncture, located in the upper limb * First fistula for a hemodialysis patient * Expected duration of dialysis ≥ 1 year * Double-needle dialysis * Hemodialysis possible on AVF * Average AVF flow rate between 500 and 2,000 mL/min * Affiliated with a social security scheme * Free and informed consent Exclusion Criteria: * Auto-dialysis at home * Puncture using the buttonhole technique * Patient requiring AVF puncture with a catheter * Planned transplant within the next 12 months * Previous AVF creation, except for the fistula of interest * Patient with a history of cancer within the past 5 years or active cancer * Patient under court protection or guardianship * Pregnant and breast-feeding women * Patient with psychiatric pathologies or cognitive disorders * Patient follow-up difficult or impossible for geographical or other reasons, at the investigator's discretion
Where it's running
-
Centre Hospitalier Emile Roux
Le Puy-en-Velay, France Recruiting -
Hôpital Saint Joseph Saint Luc
Lyon, France Not yet recruiting -
Centre Hospitalier de Moulins-Yzeure
Moulins, France Not yet recruiting -
Ctre Hospitalier Intercommunal Poissy St Germain Site Poissy
Poissy, France Not yet recruiting
Study contacts
- Study coordinator: David SOULIER
- Email: david.soulier@ch-lepuy.fr
- Phone: 0471043875
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.