Clinical trial NCT04578353: Effect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: CHF
Edema
Lead sponsor: AquaPass Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety Events
timeFrame: 30 days
measure: System Activation
timeFrame: During procedure
measure: Treatment Toleration
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
measure: Skin Changes
timeFrame: Before and and immediately after procedure
measure: CBC
timeFrame: Before and and immediately after procedure
measure: NT-proBNP (phase 2 only)
timeFrame: Before and and immediately after procedure
measure: Serum creatinine, BUN and Sodium
timeFrame: Before and and immediately after procedure
measure: Urinary sodium concentration
timeFrame: Before and and immediately after procedure
measure: Dyspnea
timeFrame: Before and and immediately after procedure
measure: Pitting edema
timeFrame: Before and and immediately after procedure
measure: JVD
timeFrame: Before and and immediately after procedure
measure: Weight
timeFrame: During and and immediately after procedure
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: (Director, Inpatient Cardiology Unit (Rambam Health Care Campus)
name: Doron Aronson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aronson D, Nitzan Y, Petcherski S, Bravo E, Habib M, Burkhoff D, Abraham WT. Enhancing Sweat Rate Using a Novel Device for the Treatment of Congestion in Heart Failure. Circ Heart Fail. 2023 Jan;16(1):e009787. doi: 10.1161/CIRCHEARTFAILURE.122.009787. Epub 2022 Nov 2.