Taking people in FranceNo phase

Tests needle bevel direction when puncturing fistulas for dialysis

Compares needle bevel direction in adults with kidney failure on hemodialysis.

Key facts

Who runs it: Centre Hospitalier Emile Roux
Where: Le Puy-en-Velay, Lyon, Moulins, and Poissy, FranceSee the 4 sites
Trial code: NCT06708338
Registry title: Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis
Status: Recruiting
People taking part: 240 people, planned
Started: 7 Jan 2026
Expected to end: 30 Jun 2029
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Needle bevel orientation for arteriovenous fistula puncture
Record updated: 4 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic kidney disease who get hemodialysis in a dialysis center through their first arteriovenous fistula, which has never been punctured before. It compares two needle bevel positions.

Age: 18 to 85 years
Sex: Men and women can join.
Disease stage: Chronic kidney disease needing 4-hour hemodialysis sessions, 3 times per week, with a mature native arteriovenous fistula (AVF) in the upper limb, with no prior puncture, and an average AVF flow rate between 500 and 2,000 mL/min. Dialysis is expected to last 1 year or more.
Earlier treatment: The fistula must be the person's first one, with no prior puncture. Dialysis uses double needles. People who use the buttonhole technique or a catheter for puncture cannot join.

Main reasons for not taking part

Dialysis at home on their own
A transplant planned within the next 12 months
Cancer in the past 5 years or active cancer
Pregnant or breast-feeding women
Psychiatric illness or cognitive disorders

This trial only enrols participants on dialysis. The registry sentence this rests on: patient requiring 4-hour hemodialysis sessions, 3 times per week, in a dialysis center

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

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

Who cannot take part

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 with psychiatric pathologies or cognitive disorders
Auto-dialysis at home
Puncture using the buttonhole technique
Patient requiring AVF puncture with a catheter
Patient under court protection or guardianship
Pregnant and breast-feeding women
Patient follow-up difficult or impossible for geographical or other reasons, at the investigator's discretion

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 85 years old?

Where in France

Centre Hospitalier Emile RouxLe Puy-en-Velay, FranceContact: Claire REYMONDTaking people
Hôpital Saint Joseph Saint LucLyon, FranceContact: Sophie MILLETNot yet recruiting
Centre Hospitalier de Moulins-YzeureMoulins, FranceContact: Nelly DOMPNIERNot yet recruiting
Ctre Hospitalier Intercommunal Poissy St Germain Site PoissyPoissy, FranceContact: Hanan TANOUTINot yet recruiting

About the trial

What the trial wants to find out

End-stage renal disease (ESRD) is a condition in which the filtration function of the kidneys has deteriorated, necessitating dialysis or transplantation. With an aging population, the number of patients undergoing dialysis for CKD is constantly increasing.

Read full original descriptionShow less

There are different types of dialysis treatment: hemodialysis and peritoneal dialysis.

Hemodialysis involves exchanges between blood and a dialysate (a liquid used to purify blood) via a dialyzer (artificial filter), coordinated by a generator. This method requires a vascular approach, of which there are 3 types: the arteriovenous fistula (AVF), the arteriovenous graft and the central venous catheter.

The AVF remains the vascular access of choice for hemodialysis sessions, and its preservation is an essential objective for patients with CKD.

One of the major challenges for AVFs is to achieve a successful puncture, an act performed around 310 times a year per patient, for dialysis performed three times a week with double needles. This repeated procedure can cause damage to the AVF, leading to complications such as stenosis, thrombosis, aneurysm, superficial infection, hematoma, bleeding, parietal rupture or dissection.

However, there is no official recommendation on the most conservative puncture technique for AVF. In view of the number of patients concerned and the recurrence of puncture, it would seem essential to evaluate the impact of bevel orientation on the occurrence of complications during dialysis by means of a randomized prospective study.

The 2 groups in the trial

Bevel-up groupExisting treatment, for comparison
AVF puncture will be performed with the needle bevel facing up for the entire duration of the patient's participation.
Treatment: Needle bevel orientation for arteriovenous fistula puncture
Bevel-down groupTreatment being tested
AVF puncture will be performed with the needle bevel facing down for the entire duration of the patient's participation
Treatment: Needle bevel orientation for arteriovenous fistula puncture