End-Stage Renal Disease Requiring HaemodialysisFAVORINCT06708338
Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis
A study testing Needle bevel orientation for arteriovenous fistula puncture in people with End-Stage Renal Disease Requiring Haemodialysis, run by Centre Hospitalier Emile Roux at 4 sites in France.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End-Stage Renal Disease Requiring Haemodialysis
- What is being tested?
- Needle bevel orientation for arteriovenous fistula puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesFrance
- Study dates
- 7 Jan 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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 join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Camille FARCY contact
France4 sites, 4 recruiting
- Recruiting
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000
Claire REYMOND, 0471043403, claire.reymond@ch-lepuy.fr
Julie GROS, julie.gros@ch-lepuy.fr
- Not yet recruiting
Hôpital Saint Joseph Saint Luc
Lyon, 69007
Sophie MILLET, +33 4 78 61 87 14, smillet@chsjsl.fr
Sophie MILLET
- Not yet recruiting
Centre Hospitalier de Moulins-Yzeure
Moulins, 03000
Nelly DOMPNIER, +33 4 70 35 79 69, n.dompnier@ch-moulins-yzeure.fr
Nelly DOMPNIER
- Not yet recruiting
Ctre Hospitalier Intercommunal Poissy St Germain Site Poissy
Poissy, 78303
Hanan TANOUTI, +33 1 39 27 52 48, hanan.tanouti@ght-yvelinesnord.fr
Hanan TANOUTI
About this study
Official title: Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis: A Multicenter Randomized Comparative Study
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.
There are different types of dialysis treatment: hemodialysis and peritoneal dialysis.
Read more
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.
- Being tested
- Needle bevel orientation for arteriovenous fistula puncture
- Keywords
- arteriovenous fistula, puncture technique, vascular approach
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle bevel orientation for arteriovenous fistula punctureProcedure or surgery
For the duration of the study (24 months from inclusion), the nurse will puncture the AVF according to the patient's randomization arm.
Patients will be randomized, according to the minimization technique, in a 1:1 ratio between the following two groups:
- Bevel-up group
- Bevel-down group
| Study group | Role | What they receive |
|---|---|---|
| Bevel-up group | Active comparator | AVF puncture will be performed with the needle bevel facing up for the entire duration of the patient's participation. Receives: Procedure: Needle bevel orientation for arteriovenous fistula puncture |
| Bevel-down group | Experimental | AVF puncture will be performed with the needle bevel facing down for the entire duration of the patient's participation Receives: Procedure: Needle bevel orientation for arteriovenous fistula puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of needle bevel orientation (up versus down) on the occurrence of AVF complications during dialysis sessions over 12 months in patients with ESRD
The primary endpoint is the number of AVF complications over 12 months. Eight AVF complications will be collected (stenosis, thrombosis, aneurysm or aneurysm rupture, pseudoaneurysm, infection, hematoma, bleeding, rupture and/or parietal dissection).
Measured: During dialysis sessions over 12 months, from inclusion
Secondary outcomes (6)
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on the occurrence of AVF dysfunction requiring ultrasound during the first 24 months.
Time from insured bipuncture to onset of AVF dysfunction (see complications in primary endpoint) requiring ultrasound over 24 months will be calculated.
Measured: For 24 months from inclusion
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on the occurrence of an intervention (surgical or radiointerventional) during the first 24 months
Time from insured bipuncture to onset of AVF dysfunction (see complications in primary endpoint) requiring initial intervention (surgical or radio-interventional) over 24 months will be calculated.
Measured: For 24 months from inclusion
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on AVF survival.
The time between the insured bipuncture and the discontinuation of its use over 24 months by the introduction of hemodialysis sessions via a central venous catheter or another AVF will be calculated
Measured: For 24 months from inclusion
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on patient discomfort with fistula pain during and between dialysis sessions over 12 months
Patient discomfort score for AVF pain during and between dialysis sessions, assessed using a simple verbal scale with a score ranging from 0 (pain free) to 4 (unbearable pain), at each session over 12 months
Measured: For 12 months from inclusion
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on AVF wall thickening at the puncture site at 6, 12 and 24 months.
Thickening of the AVF wall at the puncture site will be measured in mm by echo-Doppler at 6, 12 and 24 months.
Measured: At 6, 12 and 24 months from inclusion
Evaluate caregivers' feedback on the two puncture techniques and any changes in their practice in terms of AVF monitoring.
Feedback from caregivers will be evaluated via a qualitative questionnaire completed every 12 months starting from the fourth patient inclusion in each center. This aims to assess their experience with the two puncture techniques and any impact on their clinical practice.
Measured: At Month 12 (if at least 4 patients have been included in the center)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start7 Jan 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal Disease Requiring HaemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Emile Roux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708338
- Sponsor's protocol ID
- RIPH2_SOULIER_FAVORI
- Other IDs
- 2024-A01536-41
- Acronym
- FAVORI
- Status last verified
- Aug 2026
- First submitted
- 25 Nov 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis: A Multicenter Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT06708338
- Acronym / sponsor ID
- FAVORI / RIPH2_SOULIER_FAVORI
- Keywords
- arteriovenous fistula, puncture technique, vascular approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Centre Hospitalier Emile RouxUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevel-up group | Active comparator | Procedure: Needle bevel orientation for arteriovenous fistula punctureAVF puncture will be performed with the needle bevel facing up for the entire duration of the patient's participation. |
| Bevel-down group | Experimental | Procedure: Needle bevel orientation for arteriovenous fistula punctureAVF puncture will be performed with the needle bevel facing down for the entire duration of the patient's participation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needle bevel orientation for arteriovenous fistula punctureFor the duration of the study (24 months from inclusion), the nurse will puncture the AVF according to the patient's randomization arm. Patients will be randomized, according to the minimization technique, in a 1:1 ratio between the following two groups: * Bevel-up group * Bevel-down group | Procedure or surgery | Bevel-down group, Bevel-up group |
Primary outcome
Evaluate the impact of needle bevel orientation (up versus down) on the occurrence of AVF complications during dialysis sessions over 12 months in patients with ESRD
Time frame: During dialysis sessions over 12 months, from inclusion
The primary endpoint is the number of AVF complications over 12 months. Eight AVF complications will be collected (stenosis, thrombosis, aneurysm or aneurysm rupture, pseudoaneurysm, infection, hematoma, bleeding, rupture and/or parietal dissection).
6 secondary outcomes
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on the occurrence of AVF dysfunction requiring ultrasound during the first 24 months.
Time frame: For 24 months from inclusion
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on the occurrence of an intervention (surgical or radiointerventional) during the first 24 months
Time frame: For 24 months from inclusion
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on AVF survival.
Time frame: For 24 months from inclusion
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on patient discomfort with fistula pain during and between dialysis sessions over 12 months
Time frame: For 12 months from inclusion
Evaluate, in patients with CKD treated with hemodialysis, the impact of bevel orientation (up versus down) on AVF wall thickening at the puncture site at 6, 12 and 24 months.
Time frame: At 6, 12 and 24 months from inclusion
Evaluate caregivers' feedback on the two puncture techniques and any changes in their practice in terms of AVF monitoring.
Time frame: At Month 12 (if at least 4 patients have been included in the center)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camille FARCY contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needle bevel orientation for arteriovenous fistula puncture in people with End-Stage Renal Disease Requiring Haemodialysis, run by Centre Hospitalier Emile Roux at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David SOULIER (0471043875, david.soulier@ch-lepuy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact of needle bevel orientation (up versus down) on the occurrence of AVF complications during dialysis sessions over 12 months in patients with ESRD (time frame: During dialysis sessions over 12 months, from inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.