NCT07017933

Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: 3ive Labs · Industry
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Impairment After Cardiac Surgery
• Renal Impairment
• Acute Kidney Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-16
• Primary completion: 2026-12-31
• Completion: 2027-06-14
• First posted: 2025-06-12
• Last updated: 2026-03-19

Locations

7 sites across 2 countries: United States, Poland

Regulatory

• FDA-regulated device study