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RECRUITING

NCT07017933

Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

Sponsor: 3ive Labs

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

22 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2025-07-16

Completion Date

2027-06-14

Last Updated

2026-03-19

Healthy Volunteers

Conditions

Renal Impairment After Cardiac Surgery Renal Impairment Acute Kidney Injury

Interventions

DEVICE

Renal assist device

The JuxtaFlow RAD includes two endoscopically placed ureteral catheters connected to a bedside pump system. The catheters are designed to deliver a mild, controlled negative pressure (-15 mmHg ± 2mmHg) into the renal pelvis of each kidney for up to 72 hours. This pressure is designed to diffuse through each of the million nephrons lowering intratubular pressure thereby improving the filtration gradient at the glomerulus while supporting overall kidney function.

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

Locations (7)

Cleveland Clinic Florida

Weston, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

University of North Carolina

Chapel Hill, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

American Heart of Poland

Bielsko-Biala, Poland

Poznan University of Medical Sciences

Poznan, Poland

Medicover Hospital

Warsaw, Poland