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

Not Applicable

Completed

• Conditions: Chronic Heart Failure
• Interventions: Device: The AquaPass System

• Registration Number: NCT04578353
• Lead Sponsor: AquaPass Medical Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2020-01-28
• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-08
• Primary Completion: 2022-02-12
• Study Completion: 2022-06-12
• Status Verified: 2022-08
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel