Clinical trial NCT06358365: Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients
Official title: Evaluation of the Safety & Performance of the Aquapass -Medical Device, for Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Failure
Chronic Kidney Diseases
Lead sponsor: AquaPass Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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/d"l

Primary outcomes:
measure: Differences in weight gain over the long interdialytic period
timeFrame: Up to 50 days
measure: Device related Adverse Events
timeFrame: Up to 60 Days
Secondary outcomes:
measure: Changes in NT-proBNP
timeFrame: Up to 50 days
measure: Changes in Blood Urea Nitrogen
timeFrame: Up to 50 days
measure: Effect on Quality of Life
timeFrame: up to 50 days
measure: Affect on Ultrafiltration Rates after the long inter dialytic gap
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Nazareth
country: Israel
facility: Nazareth Hospital EMMS
state: Al Wadi Al Jawani 1611
Study officials:
affiliation: CEO
name: Zaher Armaly, MD
role: PRINCIPAL_INVESTIGATOR
References: