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Gentle suction on kidneys during heart surgery may prevent damage

NCT ID NCT07017933

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests a device called JuxtaFlow that applies mild suction to the kidneys during heart surgery. The goal is to see if it can protect kidney function in people with pre-existing kidney problems. 124 adults undergoing heart surgery with a heart-lung machine will be randomly assigned to receive the device or standard care. The study will measure changes in kidney function and any side effects.

What this could mean

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

Active substance
Renal assist device (JuxtaFlow RAD) – a device that uses mild suction on the kidneys during heart surgery
What this could lead to
If it works, this device could help prevent kidney damage in people with weak kidneys who need heart surgery, reducing complications and hospital stays.
What could go wrong
This is an early-stage trial with only 124 participants, so results may not apply to everyone. The device is new and could have unexpected side effects or simply not work as hoped.

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 124 people

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

Started

Jul 2025

Expected to finish

Jun 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

22 to 85 years

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: To be eligible for participation in this study, an individual must meet all the following criteria: 1. A candidate for elective or urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery 2. Male or Female age 22 to 85 years 3. Estimated glomerular filtration rate (eGFR) 15 - 60 mL/min/1.73m2 4. Signed and dated informed consent 5. Female patients of childbearing potential must: 1. have negative pregnancy test at the informed consent visit, 2. be using previously initiated approved and effective contraception from the informed consent visit through completion of the study \*The only recommended contraception is condoms. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Any individual, or their legally authorized representative (LAR), who does not understand the requests and risks of participating in the clinical trial or is unable to give informed consent 2. Pregnancy or lactation 3. Prior cardiac surgery within the last 6 months 4. Hemodynamic instability as determined by the Principal Investigator 5. Immunosuppression 6. Active infections (e.g. HIV, Tbc, and all types of Hepatitis) 7. History of polycystic kidney disease 8. Patients with only one active kidney or one poorly functioning kidney 9. Evidence of current kidney obstruction (e.g., Kidney stones) 10. Evidence of current hydronephrosis 11. Active upper and/or lower urinary tract infections 12. Malignancy; oncological Surgery within 5 years or ongoing antitumoral treatment 13. Ongoing sepsis or endocarditis 14. Patients who have an expected 30-day postoperative mortality greater than 10% as determined by the Principal Investigator 15. Any secondary condition as determined by the investigator that would place the subject at an increased risk or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and/or external genitals; or severe BPH 16. Unexplained/unexpected gross hematuria as determined by the Investigator 17. Current or planned treatment with an investigational drug (IND), device (IDE), or other investigational intervention within 3 months prior to or during participation in this clinical trial 18. Patients who have a current unrepaired ureteral avulsion as determined by the investigator 19. Patients otherwise contraindicated for urological interventions, including ureter guidewire placement via bladder cystoscopy and ureteral catheterization, or otherwise contraindicated for any of the other study procedures

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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.

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites in 2 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • American Heart of Poland

    RECRUITING

    Bielsko-Biala, 43-316, Poland

    Contact Email: •••••@•••••

  • Cleveland Clinic Florida

    RECRUITING

    Weston, Florida, 33331, United States

  • Medicover Hospital

    RECRUITING

    Warsaw, 02-972, Poland

    Contact Email: •••••@•••••

  • Poznan University of Medical Sciences

    ACTIVE_NOT_RECRUITING

    Poznan, 60-354, Poland

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

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