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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 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.

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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.

Conditions Studied

Acute Kidney Injury Renal Impairment Renal Impairment After Cardiac Surgery

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

FieldValue
Enrollment Target 124 participants
Start Date 2025-07-16
Est. Completion 2027-06-14
Phase NA

Sponsor

3ive Labs

2 total trials

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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, categorized as NA. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,329-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (95% lower). The listed sponsor is 3ive Labs, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.