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