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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04578353
• Other study ID #: CL-003-01
• Status: Completed
• Phase: N/A
• Start date: January 28, 2020
• Est. completion date: June 12, 2022

Study information

• Verified date: August 2022
• Source: AquaPass Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 12, 2022
• Est. primary completion date: February 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Edema
• Heart Failure

Intervention

Device:
• The AquaPass System
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.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
AquaPass Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skin Changes	Signs of burns grade 1 or more	Before and and immediately after procedure
Other	CBC	Change in Complete Blood Count	Before and and immediately after procedure
Other	NT-proBNP (phase 2 only)	Change in N-terminal prohormone of brain natriuretic peptide levels	Before and and immediately after procedure
Other	Serum creatinine, BUN and Sodium	Change in serum creatinine, blood urea nitrogen (BUN) and sodium levels	Before and and immediately after procedure
Other	Urinary sodium concentration	Change in urinary sodium concentration	Before and and immediately after procedure
Other	Dyspnea	Change in dyspnea score	Before and and immediately after procedure
Other	Pitting edema	Change in pitting edema score	Before and and immediately after procedure
Other	JVD	Change in jugular venous distention (JVD) score	Before and and immediately after procedure
Other	Weight	Changes in weight	During and and immediately after procedure
Primary	Safety Events	Device related SAE	30 days
Primary	System Activation	Ability to activate the AquaPass System and control skin temperature to levels between 33°C and 38°C	During procedure
Primary	Treatment Toleration	Subjects can tolerate at least 2 hours of treatment	During procedure