New device aims to improve dialysis access for kidney patients
NCT ID NCT02119845
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new device called FLEX-1 that creates a special blood vessel connection (called an arteriovenous fistula) for people with advanced kidney disease who need dialysis. Sixteen adults with stage 4 or 5 chronic kidney disease took part. The goal was to see if the device is safe and works well enough for regular dialysis sessions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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16 people
The number who actually took part.
- Start date
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Aug 2012
- Finished
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Apr 2013
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Italian Hospital
Asunción, 1001-1925, Paraguay
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Choosing dialysis or transplant: does a shared approach lead to better decisions?
- Can light therapy speed up dialysis fistula healing?