Chronic Heart Failure Clinical Trial
Official title:
Evaluation of the Safety & Performance of the AquaPass Medical Device, for Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Healthy Volunteers and Chronic Edematous Patients
The purpose of this study is to demonstrate safety and performance of AquaPass System for enhancing fluid transfer through the skin, by increased sweat rate, in edematous patients.
This is a prospective, single-center, open label single arm study, conducted in two phases: up to 6 healthy subjects (Phase 1) and up to 16 chronic heart failure (CHF) patients (Phase 2). After being informed about the study, requirements and potential risks, consenting patients will be enrolled and undergo 3 procedures (each procedure up to 3 (±1) hours operation), with 4-10 days between each procedure. All patients will be followed up for 7 (±2) days from final procedure. ;
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