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New device aims to simplify dialysis access for kidney patients

NCT ID NCT02119832

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 FLEX-1 to create a special blood vessel connection (arteriovenous fistula) for dialysis in 17 adults with advanced chronic kidney disease. The goal was to see if the device is safe and works well for hemodialysis. The study focused on complication rates and whether the connection could be used for most dialysis sessions.

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

17 people

The number who actually took part.

Start date

Apr 2013

Finished

Feb 2014

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 to 80 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: * Eligible for a native surgical arteriovenous fistula, as determined by the treating physician. * Adult (age \>18 years old). * Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis. * Written informed consent obtained

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome congenital arteriovenous fistula end stage renal failure

As listed by the trial registrant

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

Chronic kidney disease (CKD)

Contacts and locations

Locations

  • Italian Hospital

    Asunción, 1001-1925, Paraguay

More trials for these conditions

Other studies related to the condition(s) this trial covers.