Effect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Device: The AquaPass System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Phase 1: Healthy subjects: Age ≥ 18 Subject has been informed on the nature of the study and has provided informed consent Subject is capable of meeting study requirements Phase 2: CHF Patients: Age ≥ 18 and diagnosed with CHF Subject has 2 or more score for pitting edema Subject is taking diuretic medications at home Subject has been informed on the nature of the study and has provided informed consent Subject is capable of meeting study requirements Exclusion Criteria: Phase 1: Healthy subjects: Subject is enrolled to another clinical investigation that might interfere with this study Subject is pregnant or planning to become pregnant within the study period, or lactating mothers Subject has no known sensitivity to Neoprene Phase 2: CHF Patients: Subject is enrolled to another clinical investigation that might interfere with this study Subject is admitted to the hospital for acute decompensated or acute heart failure Subject has any known lower body skin problems (open wounds, ulcers) eGFR<15 ml/min/m2 Subject with severe peripheral arterial disease Subject is pregnant or planning to become pregnant within the study period, or lactating mothers Subject has known sensitivity to Neoprene

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AquaPass System<br>Participants will undergo 3 procedures (each procedure up to 3 (±1) hours operation) using the AquaPass System, with 4-10 days between each procedure. | Device: The AquaPass System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Events | Device related SAE | 30 days | 
| System Activation | Ability to activate the AquaPass System and control skin temperature to levels between 33°C and 38°C | During procedure | 
| Treatment Toleration | Subjects can tolerate at least 2 hours of treatment | During procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CHF, Edema