New dialysis needle aims to improve safety for kidney patients
NCT ID NCT05927532
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tested a new dialysis needle called the Argyle Safety Fistula Cannula with an anti-reflux valve. It was used in 40 adults with end-stage kidney failure who get dialysis three times a week for 12 weeks. The goal was to see if the needle is safe and works well for hemodialysis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Argyle Safety Fistula Cannula with Anti-Reflux Valve (a specialized dialysis needle)
- What this could lead to
- If successful, this cannula could make dialysis sessions safer and more reliable for people with kidney failure.
- What could go wrong
- This is a small, early-stage study with only 40 participants and no comparison group, so results may not apply to everyone. The device is already on the market in some regions, so the novelty is limited.
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
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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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40 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Dec 2024
- 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 years and older
- 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.
Show the full entry requirements Hide 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: * Subject who is aged 18 years or older who signed informed consent * Subject is undergoing in-center hemodialysis * Subject has an arteriovenous fistulae (AVF) fistula that was determined to be mature by standard clinical definition Exclusion Criteria: * Subject is enrolled in another study that could confound the results of this study, without documented pre-approval * Subject with an existing arteriovenous graft * Subjects with known allergies to plastics * Subjects who are unable to read or respond to the questionnaire about satisfaction
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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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DaVita Columbus
Columbus, Georgia, 31904, United States
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DaVita Hartford
Hartford, Connecticut, 06082, United States
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DaVita Norfolk
Norfolk, Virginia, 23505, United States
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