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

AquaPass Medical

Status: Completed

Conditions: Chronic Heart Failure

Treatments: Device: The AquaPass System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04578353

CL-003-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Phase 1: Healthy subjects:

1. Age ≥ 18
2. Subject has been informed on the nature of the study and has provided informed consent
3. Subject is capable of meeting study requirements

Phase 2: CHF Patients:

1. Age ≥ 18 and diagnosed with CHF
2. Subject has 2 or more score for pitting edema
3. Subject is taking diuretic medications at home
4. Subject has been informed on the nature of the study and has provided informed consent
5. Subject is capable of meeting study requirements

Exclusion criteria

Phase 1: Healthy subjects:

1. Subject is enrolled to another clinical investigation that might interfere with this study
2. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
3. Subject has no known sensitivity to Neoprene

Phase 2: CHF Patients:

1. Subject is enrolled to another clinical investigation that might interfere with this study
2. Subject is admitted to the hospital for acute decompensated or acute heart failure
3. Subject has any known lower body skin problems (open wounds, ulcers)
4. eGFR<15 ml/min/m2
5. Subject with severe peripheral arterial disease
6. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
7. Subject has known sensitivity to Neoprene

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

AquaPass System

Experimental group

Description:

Participants will undergo 3 procedures (each procedure up to 3 (±1) hours operation) using the AquaPass System, with 4-10 days between each procedure.

Treatment:

Device: The AquaPass System