Last update 01 Nov 2024

AquaPass Medical Ltd.

Private Company

Last update 01 Nov 2024

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Deal

Translational Medicine

Overview

Clinical Trials associated with AquaPass Medical Ltd.

NCT06401109 / Not yet recruitingNot Applicable

Evaluating the Safety and Efficacy of the AquaPass System a Renal-independent Fluid Removal System in ADHF Patients Suffering From Fluid Overload. a European Registry

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.

Start Date01 Feb 2025

Sponsor / Collaborator

AquaPass Medical Ltd.

NCT06360380 / RecruitingNot Applicable

REFORM-HF™ Reducing Fluid Overload Using Renal Independent SysteM in Heart Failure Patients

The REFORM-HF study aims to test a new technology, AquaPass, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.
Patients will wear a lightweight suit that helps remove excess fluids through their sweat.
The investigators want to see if the AquaPass system can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics.
Participants will select if to be treated at their home or in the outpatient clinic.

Start Date05 Sep 2024

Sponsor / Collaborator

AquaPass Medical Ltd.

NCT06358365 / CompletedNot Applicable

Evaluation of the Safety & Performance of the Aquapass -Medical Device, for Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients

To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin.

Start Date29 Mar 2023

Sponsor / Collaborator

AquaPass Medical Ltd.

100 Clinical Results associated with AquaPass Medical Ltd.

0 Patents (Medical) associated with AquaPass Medical Ltd.

Literatures (Medical) associated with AquaPass Medical Ltd.

01 Dec 2024·Renal failure

Harnessing the eccrine sweat glands for the management of interdialytic weight gain - a pilot study.

Article

Author: Nitzan, Yaacov ; Chernin, Gil ; Aronson, Doron ; Armaly, Zaher A

Hemodialysis patients are susceptible to excess volume accumulation, particularly over the 2-day interval (long interdialytic gap), resulting in higher interdialytic weight gain (IDWG). We thought to determine whether a novel device designed to enhance fluid and salt loss by activating the eccrine sweat glands can mitigate IDWG. Patients eligible for the study were undergoing regular hemodialysis for ≥3 months, without residual renal function, and with IDWG (as a percentage of IDWG/dry body weight) ≥2.5%. Treatments were administered at the patient's home. The primary performance endpoint was differences in weight gain over long interdialytic period with the device compared to the control period. Secondary exploratory endpoints included the need for ultrafiltration (UF) rate > 10 mL/kg/h in the post-interval dialysis. Five patients were enrolled into the pilot study (age range 26 to 69 years, 3 women). The hourly mean weight loss from sweat was 186 ± 45 g/h. The average procedure length was 4.5 h with an average fluid loss of 899 ± 283 grams per procedure. The average least-squares mean absolute difference of IDWG between the control and treatment periods was -2.0%; (95% confidence interval [CI], -2.9% to -1.2%, p < 0001). The reduction in IDWG was associated a reduction in UF rates, from 9.23 ± 3.7 mL/kg/h to 5.55 ± 2.45 mL/kg/h between the control and treatment periods (p < 0.001), resulting in a safe UF rate (<10 mL/kg/h) in all post-treatment sessions. We conclude that enhancing sweat rate can mitigate IDWG in hemodialysis patients.

01 Jan 2023·Circulation: Heart Failure

Enhancing Sweat Rate Using a Novel Device for the Treatment of Congestion in Heart Failure

Article

Author: Habib, Manhal ; Bravo, Evgeny ; Burkhoff, Daniel ; Nitzan, Yaacov ; Petcherski, Sirouch ; Abraham, William T. ; Aronson, Doron

Background:Current treatment of fluid retention in heart failure relies primarily on diuretics. However, adequate decongestion is not achieved in many patients. We aimed to study the feasibility and short-term performance of a novel approach to remove fluids and sodium directly from the interstitial compartment by enhancing sweat rate.Methods:We used a device designed to enhance fluid and salt loss via the eccrine sweat glands. Skin temperature in the lower body was increased from 35 °C to 38 °C, where the slope of the relationship between temperature and sweat production is linear. The sweat evaporates instantaneously, thus avoiding the awareness of perspiration. The primary efficacy endpoint was the ability to increase skin temperature to the desired range. A secondary efficacy endpoint was a clinically meaningful hourly sweat output, defined as ≥150 mL/h. The primary safety endpoint was any procedure-related adverse events.Results:We studied 6 normal subjects and 18 patients with congestion. Participants underwent 3 treatment sessions of up to 4 hours. Skin temperature increased to a median of 37.5 °C (interquartile range, 37.1–37.9 °C) with the median core temperature increasing by 0.2 °C (interquartile range, 0.1–0.3 °C). The median hourly weight loss during treatment was 215 g/h (interquartile range, 165–285; range, 100–344 g/h). In 80% of treatment procedures, the average sweat rate was ≥150 mL/h. There were no significant changes in hemodynamic variables or renal function and no procedure-related adverse events.Conclusions:Enhancing sweat rate was safe and resulted in a clinically meaningful fluid removal and weight loss.Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04578353.

12 Oct 2021·European Heart Journal

Enhancing sweat rate using a novel device for the treatment of congestion in heart failure

Author: Habib, M ; Bravo, E ; Petcherski, S ; Abraham, W T ; Nitzan, Y ; Burkhoff, D ; Aronson, D

AbstractBackgroundCurrent treatment of fluid retention in heart failure (HF) relies primarily on diuretics. However, adequate decongestion is not achieved in many patients.PurposeTo study the feasibility and short-term performance of a novel approach to remove fluids and sodium directly from the interstitial compartment by enhancing sweat rate.MethodsWe used a device designed to enhance fluid and salt loss via the eccrine sweat glands. Skin temperature in the lower body was increased to 35–38°, where the slope of the relationship between temperature and sweat production is linear. With this wearable device, the sweat evaporates instantaneously, thus avoiding the awareness of perspiration. The primary efficacy endpoint was the ability to increase skin temperature to the desired range without elevating the core temperature above normal range. A secondary efficacy endpoint was a clinically meaningful hourly sweat output, defined as ≥150 mL/h. The primary safety endpoint was any procedure-related adverse events.ResultsWe studied 6 normal subjects and 10 HF patients with clinical evidence of congestion and median NT-proBNP of 602 pg/mL [interquartile range 427 to 1719 pg/mL]. Participants underwent 3 treatment sessions of up to 4h. Skin temperature increased to a median of 37.5°C (interquartile range 37.1–37.9°C) with the core temperature remaining unchanged. The median total weight loss during treatment was 219±67 g/h (Figure) with a range of 100–338 g/h. In 77% of cases, the average sweat rate was ≥150 mL/h. Systolic (P=0.25) and diastolic (P=0.48) blood pressure and heart rate (P=0.11) remained unchanged during the procedure. There were no significant changes in renal function and no procedure-related adverse events.ConclusionEnhancing sweat rate was safe and resulted in a clinically meaningful fluid removal and weight loss. Further evaluation of this concept is warranted.Funding AcknowledgementType of funding sources: Private company. Main funding source(s): AquaPass Inc Weight loss due to sweat

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100 Translational Medicine associated with AquaPass Medical Ltd.

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