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Tiny trial tests best way to create dialysis access

NCT ID NCT04376567

Knowledge-focused Sponsor: Tze-Woei Tan 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This pilot study aimed to compare two standard surgical methods for creating an arteriovenous (AV) fistula in the arm for dialysis patients with kidney failure. The goal was to see if a single procedure or two separate procedures leads to better outcomes and quality of life. However, the trial was terminated early with only 2 participants enrolled, so no meaningful conclusions can be drawn.

What this could mean

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

Active substance
Procedure: one-stage or two-stage brachial basilic arteriovenous fistula creation
What this could lead to
If successful, this trial could help determine which surgical approach (one or two procedures) is better for dialysis patients needing an AV fistula, potentially improving quality of life and reducing complications.
What could go wrong
This is a very small pilot trial (only 2 participants) that was terminated early, so results may not be reliable or generalizable. No strong conclusions can be drawn.

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

2 people

The number who actually took part.

Started

Oct 2021

Finished

Nov 2023

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 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: 1. Age ≥ 18 years; 2. ESRD receiving hemodialysis in need for new hemodialysis access; 3. Candidate for one-stage and two-stage BVT procedure as judged by the enrolling investigator; 4. Greater than 3 mm diameter of upper arm basilic vein on venous duplex scan; 5. Life expectancy ≥ 12 months; Exclusion Criteria: 1. Life expectancy \< 12 months; 2. Brachial artery stenosis or occlusion; 3. A documented hypercoagulable state (defined as a known blood disorder associated with venous or arterial thrombosis); 4. Current immunosuppressive medication, chemotherapy or radiation therapy; 5. Pregnancy or lactation

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

Arterio-venous fistula End stage renal failure Hemodialysis access failure

Contacts and locations

Locations

  • Banner University Medical Center Tucson

    Tucson, Arizona, 85724, United States

More trials for these conditions

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