NCT05843201

AquaPass Device in Treatment of CHF Patients

Evaluation of Safety, Performance, and Usability of the AquaPass Device in Treatment of CHF Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: AquaPass Medical Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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: This phase will begin when the patients are hospitalized with chronic heart failure symptoms and fluid overloaded and undergo sequential treatments. This phase will be conducted using a prospective case-control design, with measuring endpoint during hospitalization and follow-up (after discharge). Phase 2: Home treatment: Upon investigator decision at discharge, patients will use Aqua-Pass device at home or at outpatient, after discharge, aiming to refine fluid management and prevent re-admission. This phase will require a separate Informed Consent Form (ICF) and will be conducted using a prospective single-group pre-post design. * A multi-center, prospective, open label, one arm study. * Chronic heart failure patients will be enrolled into the study when admitted to the hospital with fluid overload. * During the in-hospitalization treatment phase, patients will undergo up to 5 procedures with the Aqua-Pass device between 3-8 hours. * Following discharge and upon investigator decision, patients will sign a dedicated ICF and continue the Aqua-Pass treatments at home or in the outpatient clinic for up to 60 days, at a rate of 1-4 treatments per week. * Follow up assessments, either during visit or over the phone, 7±2 days from the last procedure

Conditions

• Chronic Heart Failure
• Edema
• CHF

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-20
• Primary completion: 2023-08-14
• Completion: 2023-12-12
• First posted: 2023-05-06
• Last updated: 2024-12-12

Locations

2 sites across 1 country: Israel