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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06358365
Other study ID # AQP-DCL-026
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 29, 2023
Est. completion date November 7, 2023

Study information

Verified date May 2024
Source AquaPass Medical Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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Study Design


Intervention

Device:
The AquaPass System
The system is a non-invasive, renal-independent, single-patient, multiple-use device intended for use at the hospital, outpatient clinic, or home. The system administers warm, dry air around the patient's body to create an environmental condition that activates the eccrine glands to produce sweat, in return it removes fluids from the interstitial compartment, where fluids accumulate in fluid overload.

Locations

Country Name City State
Israel Nazareth Hospital EMMS Nazareth Al Wadi Al Jawani 1611

Sponsors (1)

Lead Sponsor Collaborator
AquaPass Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences in weight gain over the long interdialytic period weight at the end of the last Hemodialysis session before AquaPass therapy subtracted from the weight in the morning of the first Hemodialysis session of the week after AquaPass therapy. Up to 50 days
Primary Device related Adverse Events Safety evaluation of device-related adverse effects Up to 60 Days
Secondary Changes in NT-proBNP Changes in biomarkers of congestion Up to 50 days
Secondary Changes in Blood Urea Nitrogen Changes in Blood Urea Nitrogen levels Up to 50 days
Secondary Effect on Quality of Life change in the quality of life measured by the Kansas City Cardiomyopathy Questionnaire. In this questionnaire the minimum score is '0' and the maximum is '100', and higher scores represent a better outcome for the patient. up to 50 days
Secondary Affect on Ultrafiltration Rates after the long inter dialytic gap Evaluation of the changes in ultrafiltration rates between the control phase and the Aquapass phase in the first dialysis session after the long interdialytic period up to 28 days
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