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Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

3ive Labs · with Fortrea · NCT07017933

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22–85 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
124
US sites recruiting
4
Study start
July 16, 2025
Record last updated
March 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Patients with renal insufficiency who undergo cardiac surgery with cardiopulmonary bypass (CPB) are at significant risk for exacerbation of renal dysfunction postoperatively. This in turn is associated with an increased risk of prolonged intensive care unit (ICU) length of stay, other comorbidities including surgical complications and 30-day mortality. Renal impairment is generally identified based on an increase in serum creatinine concentration and/or a certain magnitude decrease in estimated glomerular filtration rate (eGFR).

The JuxtaFlow® Renal Assist Device (RAD) is designed to sustain or enhance glomerular filtration perioperatively for patients with renal insufficiency by applying a mild controlled negative pressure to the collecting system via the renal pelvis, thereby increasing effective filtration pressure and reducing tubular pressure. This mechanism is designed to support the kidneys' functions during times of renal stress that would be associated with intrarenal edema, volume overload, increased venous pressure, and inflammatory response. By supporting renal function, specifically during the acute stress of CPB, JuxtaFlow holds promise to protect nephron function, decrease renal hypoxia, and provide multifactorial kidney function support to maintain their ability to manage future stress.

Being studied: Renal assist device

Conditions: Renal Impairment After Cardiac Surgery; Renal Impairment; Acute Kidney Injury

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

To be eligible for participation in this study, an individual must meet all the following criteria:

  • A candidate for elective or urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
  • Male or Female age 22 to 85 years
  • Estimated glomerular filtration rate (eGFR) 15 - 60 mL/min/1.73m2
  • Signed and dated informed consent
  • Female patients of childbearing potential must:
  • have negative pregnancy test at the informed consent visit,
  • 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:

  • 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
  • Pregnancy or lactation
  • Prior cardiac surgery within the last 6 months
  • Hemodynamic instability as determined by the Principal Investigator
  • Immunosuppression
  • Active infections (e.g. HIV, Tbc, and all types of Hepatitis)
  • History of polycystic kidney disease
  • Patients with only one active kidney or one poorly functioning kidney
  • Evidence of current kidney obstruction (e.g., Kidney stones)
  • Evidence of current hydronephrosis
  • Active upper and/or lower urinary tract infections
  • Malignancy; oncological Surgery within 5 years or ongoing antitumoral treatment
  • Ongoing sepsis or endocarditis
  • Patients who have an expected 30-day postoperative mortality greater than 10% as determined by the Principal Investigator
  • 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
  • Unexplained/unexpected gross hematuria as determined by the Investigator
  • 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
  • Patients who have a current unrepaired ureteral avulsion as determined by the investigator
  • 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

Recruiting US locations

  • Cleveland Clinic Florida

    Weston, FL 33331

    Site contact: Rene Aleman, MD · 866-293-7866 · alemanr2@ccf.org

  • University of Michigan

    Ann Arbor, MI 48109

    Site contact: China Green · (734) 764-5500 · chjgreen@med.umich.edu

  • University of North Carolina

    Chapel Hill, NC 27514

    Site contact: Michelle Becton · 919-843-2698 · michelle_becton@med.unc.edu

  • University of Cincinnati

    Cincinnati, OH 45267

    Site contact: Devin M Wakefield, MSc, CCRC · 513-558-7247 · wakefidm@ucmail.uc.edu

Study contacts (from the official record)

  • Allison Fenderson, RN, MSHS, CCRP · 919-744-5703 · gradient@3ivelabs.com
  • Alencia Washington, PhD · gradient@3ivelabs.com
Groundbreaking Renal Assist Device Intervening to ENhance… (NCT07017933) | Bored Studies