Acute Kidney FailureNCT06358365
Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients
A study testing The AquaPass System in people with Acute Kidney Failure and Chronic Kidney Diseases, run by AquaPass Medical Ltd. at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure, Chronic Kidney Diseases
- What is being tested?
- The AquaPass System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- 29 Mar 2023to 7 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Undergoing regular hemodialysis for ≥3 months
- Subject is capable of meeting study requirements including follow-up visit
- Subject completed 2-hour acclimatization session
Who cannot join
- Subject is enrolled to another clinical investigation that might interfere with this study
- Subject does not have any known skin problems (open or uncovered wounds, ulcers)
- Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
- Scheduled living donor renal transplant during study participation
- Has resting pre-dialysis systolic blood pressure <100mmHg
- Limb/s amputation
- Hyperkalemia > 6meq/d"l
Trial locations and contacts
1 site in 1 country.
About this study
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
To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin.
Read the 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.
- Conditions
- Acute Kidney Failure, Chronic Kidney Diseases
- Being tested
- The AquaPass System
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The AquaPass SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| adult patients undergoing regular hemodialysis | Experimental | This study will be a crossover study with one center and an open label design. Patients who sign the informed consent form and meet the inclusion and exclusion criteria will undergo a 2-hour acclimatization period to verify their ability to adhere to the AquaPass procedure. Once enrolled, patients will undergo a 3-week observation period where they will continue with their regular hemodialysis treatment with no changes. Study endpoint parameters will be assessed during this observation period and used as a control group. After the observation period, patients will undergo the AquaPass procedure 2-3 times a week for 4 weeks. Study assessments will be conducted at the beginning of each week during the patient's dialysis session. Receives: Device: The AquaPass System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 50 days
Device related Adverse Events
Safety evaluation of device-related adverse effects
Measured: Up to 60 Days
Secondary outcomes (4)
Changes in NT-proBNP
Changes in biomarkers of congestion
Measured: Up to 50 days
Changes in Blood Urea Nitrogen
Changes in Blood Urea Nitrogen levels
Measured: Up to 50 days
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.
Measured: up to 50 days
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
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start29 Mar 2023
- Primary completion2 Nov 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- AquaPass Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zaher Armaly, MD, Principal investigator, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358365
- Sponsor's protocol ID
- AQP-DCL-026
- Status last verified
- May 2024
- First submitted
- 15 Jan 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06358365
- Acronym / sponsor ID
- AQP-DCL-026
- Conditions
- Acute Kidney Failure, Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- AquaPass Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients undergoing regular hemodialysis | Experimental | Device: The AquaPass SystemThis study will be a crossover study with one center and an open label design. Patients who sign the informed consent form and meet the inclusion and exclusion criteria will undergo a 2-hour acclimatization period to verify their ability to adhere to the AquaPass procedure. Once enrolled, patients will undergo a 3-week observation period where they will continue with their regular hemodialysis treatment with no changes. Study endpoint parameters will be assessed during this observation period and used as a control group. After the observation period, patients will undergo the AquaPass procedure 2-3 times a week for 4 weeks. Study assessments will be conducted at the beginning of each week during the patient's dialysis session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Undergoing regular hemodialysis for ≥3 months
- Subject is capable of meeting study requirements including follow-up visit
- Subject completed 2-hour acclimatization session
Key exclusion criteria (7 listed)
- Subject is enrolled to another clinical investigation that might interfere with this study
- Subject does not have any known skin problems (open or uncovered wounds, ulcers)
- Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
- Scheduled living donor renal transplant during study participation
- Has resting pre-dialysis systolic blood pressure <100mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The AquaPass SystemThe 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. | Device | adult patients undergoing regular hemodialysis |
Primary outcome
Differences in weight gain over the long interdialytic period
Time frame: 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
Time frame: Up to 60 Days
Safety evaluation of device-related adverse effects
4 secondary outcomes
Changes in NT-proBNP
Time frame: Up to 50 days
Changes in Blood Urea Nitrogen
Time frame: Up to 50 days
Effect on Quality of Life
Time frame: up to 50 days
Affect on Ultrafiltration Rates after the long inter dialytic gap
Time frame: up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Failure
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaher Armaly, MD principal investigator
CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The AquaPass System in people with Acute Kidney Failure and Chronic Kidney Diseases, run by AquaPass Medical Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in weight gain over the long interdialytic period (time frame: Up to 50 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.