AquaPass Device in Treatment of CHF Patients
NCT05843201 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2024-12-12
Summary
The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients.
This study will examine safety, performance and usability of the AquaPass device in two phases:
Phase 1: Hospitalization treatment. Phase 2: Home/outpatient clinic treatment
Conditions
Interventions
- DEVICE
-
The AquaPass System
The system is a non-invasive, multiple use device intended for use at the hospital, at the outpatient clinic settings or at home. The system administers warm, dry air around the patients' body in order to create environmental conditions that increase the patients' sweat rate. Throughout the treatment, fluids from the interstitial compartment are removed from the body by the eccrine sweat glands.
Sponsors & Collaborators
-
AquaPass Medical Ltd.
lead INDUSTRY
Principal Investigators
-
Doron Aronson, Prof. · Rambam MC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-20
- Primary Completion
- 2023-08-14
- Completion
- 2023-12-12
Countries
- Israel
Study Locations
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