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New hope for dialysis patients: special grafts studied for those with no vein options left

NCT ID NCT06422871

Knowledge-focused Sponsor: Merit Medical Systems, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 100 adults with end-stage kidney disease who need long-term dialysis but have no working access sites left. Researchers are watching how well the HeRO and Super HeRO grafts perform over two years, checking for infections, blockages, and overall safety. The goal is to better understand if these devices can provide a reliable lifeline for patients who have exhausted other options.

What this could mean

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

Active substance
HeRO Graft System or Super HeRO System (medical device)
What this could lead to
If successful, this study could confirm that these grafts are a safe and effective long-term option for dialysis patients who have run out of other access choices.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove the device works better than alternatives. Results may be limited by the small number of participants and lack of a comparison group.

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.

Participants

About 100 people

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

Started

Jul 2025

Expected to finish

Dec 2028

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.

Who is studied

End-stage renal disease patients on hemodialysis who have exhausted all other access options.

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.

Key Inclusion Criteria: * Subject provides written informed consent * Subject is ≥ 18 years * Subject is end-stage renal disease patient on hemodialysis. * Subject is treated with HeRO Graft or Super HeRO System in accordance with device instructions for use (IFU) Key Exclusion Criteria: * Subject has a previously placed HeRO or Super HeRO device that is undergoing revision or replacement * Subject has a topical or subcutaneous infection associated with the implantation site * Subject has known or suspected systemic infection, bacteremia or septicemia

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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 Hemodialysis access failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor Scott & White Heart and Vascular Hospital - Dallas

    RECRUITING

    Dallas, Texas, 75226, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • MedStar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Sarasota Memorial Health Care System

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • University Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15219, United States

  • WakeMed

    RECRUITING

    Raleigh, North Carolina, 27610, United States

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