RecruitingNot ApplicableNCT05759806

Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF


Sponsor

Nephronyx LTD

Enrollment

10 participants

Start Date

Dec 19, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this interventional study is to evaluate the safety and functional performance of the Nephronyx System in patients with ADHF, presenting clinical signs of volume overload and compromised response to diuretics.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new medical device called the Nephronyx System in people who are hospitalized with acute decompensated heart failure (ADHF) — a condition where the heart suddenly becomes unable to pump blood properly, causing dangerous fluid buildup — and whose kidneys are not responding well to diuretic (water pill) medications. **You may be eligible if...** - You are admitted to hospital primarily because of severe heart failure - You have visible signs of excess fluid in your body - Your heart pumping function is above 15% - Your kidneys are not responding adequately to diuretics (water pills) - Your blood marker for heart stress (NT-proBNP or BNP) is elevated **You may NOT be eligible if...** - You have a blood clot in your leg veins (DVT) or history of DVT - You have a narrowing of the arteries supplying your kidneys - Your BMI is above 35 - You have untreated abnormal heart rhythms or recent heart procedures - You have severe kidney disease requiring dialysis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENephronyx system (Perfuser)

Temporary deployment of the Nephronyx system (Perfuser)


Locations(4)

Rambam Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

The Baruch Padeh Medical Center, Poriya

Poria Illit, Israel

Kaplan Medical Center

Rehovot, Israel

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NCT05759806


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