Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AquaPass System | Experimental | Participants will undergo 3 procedures (each procedure up to 3 (±1) hours operation) using the AquaPass System, with 4-10 days between each procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The AquaPass System | Device | 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. |
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Skin Changes | Signs of burns grade 1 or more | Before and and immediately after procedure |
| CBC | Change in Complete Blood Count | Before and and immediately after procedure |
Inclusion Criteria:
Phase 1: Healthy subjects:
Phase 2: CHF Patients:
Exclusion Criteria:
Phase 1: Healthy subjects:
Phase 2: CHF Patients:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Doron Aronson, Professor | (Director, Inpatient Cardiology Unit (Rambam Health Care Campus) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36321445 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| NT-proBNP (phase 2 only) | Change in N-terminal prohormone of brain natriuretic peptide levels | Before and and immediately after procedure |
| Serum creatinine, BUN and Sodium | Change in serum creatinine, blood urea nitrogen (BUN) and sodium levels | Before and and immediately after procedure |
| Urinary sodium concentration | Change in urinary sodium concentration | Before and and immediately after procedure |
| Dyspnea | Change in dyspnea score | Before and and immediately after procedure |
| Pitting edema | Change in pitting edema score | Before and and immediately after procedure |
| JVD | Change in jugular venous distention (JVD) score | Before and and immediately after procedure |
| Weight | Changes in weight | During and and immediately after procedure |