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NCT07017933 · ClinicalTrials.gov registry record · NA
Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes
A NA study of Acute Kidney Injury and Renal Impairment, sponsored by 3ive Labs.
- Recruiting
- Registry status
- NA
- Development phase
- 124
- Enrollment target
- 7
- Study locations
NCT07017933: Recruiting NA study of Acute Kidney Injury and Renal Impairment, sponsored by 3ive Labs.
NCT07017933 is a NA study of Acute Kidney Injury and Renal Impairment that is actively recruiting participants, run by 3ive Labs. The registered enrollment target is 124 participants, below the 2,329-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (95% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07017933, a NA study of Acute Kidney Injury and Renal Impairment, is actively recruiting participants, sponsored by 3ive Labs.
- RECRUITING
- Registry status
- NA
- Development phase
- 124 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
The mean peak percent change in serum creatinine from baseline values (prior to treatment) within the first 96 hours post-surgery for JuxtaFlow treated subjects as compared to controls.
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 |
What NCT07017933 shows while recruiting
NCT07017933 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 2,329-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (95% lower).
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.
NCT07017933 lists 7 locations in 5 states (Other, Florida, Michigan).
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.
What interventions are being tested in trial NCT07017933?
The interventions under investigation include: Renal assist device (DEVICE).
Who is sponsoring clinical trial NCT07017933?
This trial is sponsored by 3ive Labs, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT07017933's enrollment target sits among peer trials
124 41st of 74 higher than 32 of 74 other Acute Kidney Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Kidney Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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