Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients, a European Registry
NCT06401109 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-05-06
Summary
The AquaPass is a non-invasive, renal-intended system designed to enhance fluid transfer through the skin, by increasing sweat rate, to treat fluid overload in heart failure patients.
This study will further evaluate the safety, efficacy, and usability of the AquaPass system in the hospital and home settings.
Conditions
- Chronic Heart Failure
- Fluid Overload
- Acute Decompensated Heart Failure
- Edema
Interventions
- DEVICE
-
AquaPass
The AquaPass system works by activating the body's natural sweating mechanism to remove excess fluid from the interstitial compartment. This process is achieved by wearing a garment that creates optimal microclimate conditions around the skin. The system is controlled by a portable unit that delivers warm air to the wearable component while ensuring patient safety.
Sponsors & Collaborators
-
AquaPass Medical Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-28
- Primary Completion
- 2026-02-28
- Completion
- 2026-05-31
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