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New dialysis graft aims to reduce blockages and infections

NCT ID NCT05729620

Disease control Sponsor: Healionics Corporation 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new device called STARgraft-3, a tube used for dialysis in people with end-stage kidney disease. The goal is to see if it stays open longer and resists infection better than standard grafts. About 21 adults will be followed for up to a year to check how well the graft works.

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

About 21 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

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: 1. Male or female, \> 18 years or age. 2. Patient has given informed consent to participate in the trial. 3. Stated willingness to comply with all study procedures and availability for the duration of the study. 4. Able to effectively communicate with study personnel. 5. Candidate for a new arterio-venous graft placed in the upper arm. 6. Life expectancy judged to be at least 2 years. 7. Axillary vein of greater than or equal to 7 mm in diameter. 8. Brachial artery of greater than or equal to 4 mm in diameter. 9. Acceptable cardiac risk level (Cardiac Output ≥ 3.5 L/min, Pulmonary Artery Pressure ≤ 50 mmHg, Ejection Fraction ≥ 40%) 10. Systolic blood pressure equal to or greater than 120 mmHg. 11. Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram. Exclusion Criteria: 1. Unable or unlikely to comply with trial protocol and/or follow-up. 2. Pregnancy. 3. Clinically morbid obesity. 4. Anatomical limitations. 5. Immunodeficiency syndrome. 6. History of bacterial infection within 8 weeks prior to graft implantation. 7. History of hypercoagulation or bleeding disorders. 8. Elevated platelet count \> 1 million per microliter of blood. 9. History of heparin-induced thrombocytopenia syndrome (HIT). 10. Medically confirmed stenosis of the veins downstream of the implant site. 11. Inadequate arterial flow or pressure proximal to the implant site. 12. Currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial. 13. Fever greater than 38°C. 14. Prior allergic reaction to silicone. 15. Confirmed or suspected COVID-19 infection within 8 weeks prior to graft implant, or ongoing COVID-19 symptoms.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease end stage renal failure

As listed by the trial registrant

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

End-stage renal disease

Contacts and locations

Locations

  • Italian Hospital

    Asunción, Paraguay

More trials for these conditions

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