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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
The AquaPass device is a capsule that creates relatively homogenous temperature around the patients' lower body, while controlling and maintaining at a low percentage the relative humidity within the capsule thus enabling controlled environment that enhances sweat rate.
Rambam Health Care Campus
Haifa, Israel
Safety Events
Device related SAE
Time frame: 30 days
System Activation
Ability to activate the AquaPass System and control skin temperature to levels between 33°C and 38°C
Time frame: During procedure
Treatment Toleration
Subjects can tolerate at least 2 hours of treatment
Time frame: During procedure
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