AquaPass Device in Treatment of CHF Patients

NCT05843201 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-12-12

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05843201 on ClinicalTrials.gov