NCT05759806Recruiting
Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
Source: ClinicalTrials.gov · Last updated 25 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 26 Feb 2023
- Start date
- 19 Dec 2022
- Primary completion date
- Jun 2026
- Lead sponsor
- Nephronyx LTD
- Diseases
- Heart failure
- NCT number
- NCT05759806
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 19 Dec 2022 to the primary completion date, Jun 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient with active DVT or history of DVT
- Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization
- Patient has blood dyscrasia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy
- Temperature \> 38°C, or sepsis, or active systemic infection requiring IV anti-microbial treatment
Other
- Patient has documented or evidence of Renal artery stenosis
- BMI\>35 Kg/m\^2
- Patient is in Cardiogenic shock
- Patient has shown liver cirrhosis or has signs of liver damage
Who the study is looking for
- Patient admitted to the hospital with a primary diagnosis of ADHF
- Patient has signs of volume overload as evidence by a score of ≥ 4 on the EVEREST score
- Patient with Left Ventricular Ejection Fraction LVEF \>15%
- Patient has compromised response to diuretics
- NT-proBNP \>450 pg/mL if aged \<55 years, \>900 pg/mL if aged between 55 and 75 years and \>1800 pg/mL if aged \>75 years
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| The Baruch Padeh Medical Center, Poriya Coordinator of this site? Confirm its status | Poria Illit | Israel | Recruiting |
| Kaplan Medical Center Coordinator of this site? Confirm its status | Rehovot | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.