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Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes
NCT07017933 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE Renal assist device
Study Locations (7)
Other
- American Heart of Poland — Bielsko-Biala
- Poznan University of Medical Sciences — Poznan
- Medicover Hospital — Warsaw
Florida
- Cleveland Clinic Florida — Weston
Michigan
- University of Michigan — Ann Arbor
North Carolina
- University of North Carolina — Chapel Hill
Ohio
- University of Cincinnati — Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2025-07-16 |
| Est. Completion | 2027-06-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07017933
The ClinicalTrials.gov registry entry for NCT07017933 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is 3ive Labs, which has 28 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Acute Kidney Injury appearing as the primary indexed condition, and to 1 intervention — of which Renal assist device is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07017933 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Other, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07017933 about?
NCT07017933 is a clinical study titled "Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes". 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 ...
What is the current status of trial NCT07017933?
This trial is currently recruiting. It is a NA study. The enrollment target is 124 participants. The study started on 2025-07-16. Estimated completion is 2027-06-14.
What conditions does trial NCT07017933 study?
This clinical trial studies the following conditions: Acute Kidney Injury, Renal Impairment, Renal Impairment After Cardiac Surgery. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07017933?
The interventions under investigation include: Renal assist device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07017933?
This trial is sponsored by 3ive Labs, which has 28 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07017933 being conducted?
This trial has 7 study locations across Florida, Michigan, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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