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A simple needle twist could save dialysis fistulas

NCT ID NCT06708338

Disease control Sponsor: Centre Hospitalier Emile Roux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial tests whether the direction of the needle bevel (up or down) during fistula puncture affects the risk of complications in people on hemodialysis. About 240 adults with end-stage kidney disease who are starting dialysis with a new arteriovenous fistula will be randomly assigned to one of two puncture techniques. Over 12 months, researchers will track complications like narrowing, clotting, bleeding, and infection to see if one bevel orientation is gentler on the fistula.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Needle bevel orientation (up vs down) for arteriovenous fistula puncture
What this could lead to
If one bevel direction proves safer, it could become the standard way to puncture fistulas, reducing painful and dangerous complications for dialysis patients.
What could go wrong
This is a procedure-based study, and results may not show a clear difference. Complications can still occur regardless of bevel direction, and the trial's findings may not apply to all patients or fistula types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

congenital arteriovenous fistula end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

End-stage renal disease requiring haemodialysis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Hospitalier Emile Roux

    RECRUITING

    Le Puy-en-Velay, 43000, France

  • Centre Hospitalier de Moulins-Yzeure

    NOT_YET_RECRUITING

    Moulins, 03000, France

  • Ctre Hospitalier Intercommunal Poissy St Germain Site Poissy

    NOT_YET_RECRUITING

    Poissy, 78303, France

  • Hôpital Saint Joseph Saint Luc

    NOT_YET_RECRUITING

    Lyon, 69007, France

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