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New tube system could make dialysis access easier for kidney patients

NCT ID NCT02036671

Disease control Sponsor: C. R. Bard Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new device called the FLEX System that creates a connection between an artery and a vein (AV fistula) using a tube inserted through the skin, instead of surgery. The goal was to see if this method is safe and works well for people with chronic kidney disease who need dialysis. 80 adults with kidney failure participated. The study measured how many fistulas matured enough for dialysis and how many serious side effects occurred.

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

80 people

The number who actually took part.

Start date

Jan 2014

Finished

Oct 2016

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: * Eligible for a native surgical arteriovenous fistula, as determined by the treating physician. * Adult (age \>18 years old). * Established, non-reversible kidney failure requiring hemodialysis. * Written informed consent obtained. Exclusion Criteria: * Functioning surgical access in the planned treatment arm. * Pregnant women. * New York Heart Association (NYHA) class III or IV heart failure. * Allergy to contrast dye.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome congenital arteriovenous fistula Fistula kidney disorder kidney failure urinary system disorder

As listed by the trial registrant

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

Chronic kidney disease

Contacts and locations

Locations

  • Alfred Hospital

    Melbourne, Victoria, 3181, Australia

  • Auckland City Hospital

    Grafton, 1142, New Zealand

  • CHUM, Notre-Dame Hospital

    Montreal, Quebec, H2L 4M1, Canada

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9, Canada

  • London Health Sciences Centre

    London, Ontario, N6A 5W9, Canada

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • QE II Health Sciences Center

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • The Toronto General Hospital

    Toronto, Ontario, M5G 2C4, Canada

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