Acute Kidney Failure, Chronic Kidney Diseases
Conditions
Brief summary
To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin.
Detailed description
This study requires several investigational tests, exams, and data collection procedures to be performed by the participants. These procedures are listed in abbreviated format in the Schedule of Assessments/Activities table. The final eligibility of the trial will be confirmed after a 2-hour acclimatization session. The trial-specific procedures must not be performed until the participant has signed a written informed consent form, which has been approved by the site's Institutional Review Board. The investigator or designee, who is trained in the clinical investigation plan, will explain the nature and scope of the trial to the participant. They will also discuss the potential risks and benefits of participation and answer any questions the participant may have. If the participant agrees to participate, they must sign the informed consent form. The investigator/designee must also sign the form before the participant can be enrolled in the trial. Any additional persons required by the site's Institutional Review Board to sign the informed consent form must also comply. Each participant's study duration will be approximately 8 weeks. The study duration will be identical for all participants, as follows: Screening Period: This period will last up to 7 days, during which time the participant's eligibility for the trial will be determined. Observation Period: This period will last 3 weeks, during which the participant will come to the medical study center for weekly assessments. Procedure Period: This period will last 4 weeks, during which time the participant will undergo 2-3 procedures with the AquaPass device each week. These procedures will be in addition to their regular hemodialysis treatment. The participant will undergo 2 procedures during the weekend, and each procedure will last 3-8 hours. Follow-Up: This period will last 7(±1) days from the last procedure. During this period, the participant's health status will be monitored. In summary, the study requires participants to undergo several investigational tests, exams, and data collection procedures. The study duration for each participant will be approximately 8 weeks, during which time they will undergo a screening period, observation period, procedure period, and follow-up period. All participants must provide written informed consent before any trial-specific procedures can be performed.
Interventions
DEVICEThe 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.
Sponsors
AquaPass Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 2. Undergoing regular hemodialysis for ≥3 months 3. Subject is capable of meeting study requirements including follow-up visit 4. Subject completed 2-hour acclimatization session
Exclusion criteria
1. Subject is enrolled to another clinical investigation that might interfere with this study 2. Subject does not have any known skin problems (open or uncovered wounds, ulcers) 3. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers 4. Scheduled living donor renal transplant during study participation 5. Has resting pre-dialysis systolic blood pressure \<100mmHg 6. Limb/s amputation 7. Hyperkalemia \> 6meq/dl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in weight gain over the long interdialytic period | Up to 50 days | 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. |
| Device related Adverse Events | Up to 60 Days | Safety evaluation of device-related adverse effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in NT-proBNP | Up to 50 days | Changes in biomarkers of congestion |
| Changes in Blood Urea Nitrogen | Up to 50 days | Changes in Blood Urea Nitrogen levels |
| Effect on Quality of Life | up to 50 days | 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. |
| Affect on Ultrafiltration Rates after the long inter dialytic gap | up to 28 days | 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 |
Countries
Israel
Outcome results
None listed