Chronic Heart FailureNCT04578353
Effect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous Patients
A study testing The AquaPass System in people with Chronic Heart Failure, run by AquaPass Medical Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to demonstrate safety and performance of AquaPass System for enhancing fluid transfer through the skin, by increased sweat rate, in edematous patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- The AquaPass System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Jan 2020to 12 Jun 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase 1: Healthy subjects:
- Age ≥ 18
- Subject has been informed on the nature of the study and has provided informed consent
- Subject is capable of meeting study requirements
- Phase 2: CHF Patients:
- Age ≥ 18 and diagnosed with CHF
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- Subject has 2 or more score for pitting edema
- Subject is taking diuretic medications at home
- Subject has been informed on the nature of the study and has provided informed consent
- Subject is capable of meeting study requirements
Who cannot join
- Phase 1: Healthy subjects:
- Subject is enrolled to another clinical investigation that might interfere with this study
- Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
- Subject has no known sensitivity to Neoprene
- Phase 2: CHF Patients:
- Subject is enrolled to another clinical investigation that might interfere with this study
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- Subject is admitted to the hospital for acute decompensated or acute heart failure
- Subject has any known lower body skin problems (open wounds, ulcers)
- eGFR<15 ml/min/m2
- Subject with severe peripheral arterial disease
- Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
- Subject has known sensitivity to Neoprene
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 Healthy Volunteers and Chronic Edematous Patients
The purpose of this study is to demonstrate safety and performance of AquaPass System for enhancing fluid transfer through the skin, by increased sweat rate, in edematous patients.
Read the detailed description
This is a prospective, single-center, open label single arm study, conducted in two phases: up to 6 healthy subjects (Phase 1) and up to 16 chronic heart failure (CHF) patients (Phase 2).
After being informed about the study, requirements and potential risks, consenting patients will be enrolled and undergo 3 procedures (each procedure up to 3 (±1) hours operation), with 4-10 days between each procedure.
All patients will be followed up for 7 (±2) days from final procedure.
- Conditions
- Chronic Heart Failure
- Being tested
- The AquaPass System
- Keywords
- CHF, Edema
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The AquaPass SystemDevice
The AquaPass device is a capsule that creates relatively homogenous temperature around the patients' lower body, while controlling and maintaining at a low percentage the relative humidity within the capsule thus enabling controlled environment that enhances sweat rate.
| Study group | Role | What they receive |
|---|---|---|
| AquaPass System | Experimental | Participants will undergo 3 procedures (each procedure up to 3 (±1) hours operation) using the AquaPass System, with 4-10 days between each procedure. Receives: Device: The AquaPass System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Events
Device related SAE
Measured: 30 days
System Activation
Ability to activate the AquaPass System and control skin temperature to levels between 33°C and 38°C
Measured: During procedure
Treatment Toleration
Subjects can tolerate at least 2 hours of treatment
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start28 Jan 2020
- Primary completion12 Feb 2022
- Study completion12 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AquaPass Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doron Aronson, Professor, Principal investigator, (Director, Inpatient Cardiology Unit (Rambam Health Care Campus)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578353
- Sponsor's protocol ID
- CL-003-01
- Status last verified
- Aug 2022
- First submitted
- 25 Sep 2020
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aronson D, Nitzan Y, Petcherski S, Bravo E, Habib M, Burkhoff D, Abraham WT. Enhancing Sweat Rate Using a Novel Device for the Treatment of Congestion in Heart Failure. Circ Heart Fail. 2023 Jan;16(1):e009787. doi: 10.1161/CIRCHEARTFAILURE.122.009787. Epub 2022 Nov 2.
PubMed 36321445
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. 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 Healthy Volunteers and Chronic Edematous Patients
- ClinicalTrials.gov ID
- NCT04578353
- Acronym / sponsor ID
- CL-003-01
- Conditions
- Chronic Heart Failure
- Keywords
- CHF, Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AquaPass Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 12 Feb 2022 (actual)
- Study completion
- 12 Jun 2022 (actual)
- First posted
- 8 Oct 2020 (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.
The purpose of this study is to demonstrate safety and performance of AquaPass System for enhancing fluid transfer through the skin, by increased sweat rate, in edematous patients.
Detailed description
This is a prospective, single-center, open label single arm study, conducted in two phases: up to 6 healthy subjects (Phase 1) and up to 16 chronic heart failure (CHF) patients (Phase 2).
After being informed about the study, requirements and potential risks, consenting patients will be enrolled and undergo 3 procedures (each procedure up to 3 (±1) hours operation), with 4-10 days between each procedure.
All patients will be followed up for 7 (±2) days from final procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AquaPass System | Experimental | Device: The AquaPass SystemParticipants will undergo 3 procedures (each procedure up to 3 (±1) hours operation) using the AquaPass System, with 4-10 days between each procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18
- Subject has been informed on the nature of the study and has provided informed consent
- Subject is capable of meeting study requirements
- Age ≥ 18 and diagnosed with CHF
- Subject has 2 or more score for pitting edema
Key exclusion criteria (12 listed)
- Subject is enrolled to another clinical investigation that might interfere with this study
- Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
- Subject has no known sensitivity to Neoprene
- Subject is enrolled to another clinical investigation that might interfere with this study
- Subject is admitted to the hospital for acute decompensated or acute heart failure
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 AquaPass device is a capsule that creates relatively homogenous temperature around the patients' lower body, while controlling and maintaining at a low percentage the relative humidity within the capsule thus enabling controlled environment that enhances sweat rate. | Device | AquaPass System |
Primary outcome
Safety Events
Time frame: 30 days
Device related SAE
System Activation
Time frame: During procedure
Ability to activate the AquaPass System and control skin temperature to levels between 33°C and 38°C
Treatment Toleration
Time frame: During procedure
Subjects can tolerate at least 2 hours of treatment
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 1 Nov 2023.
- Derived from this study: PubMed 36321445Aronson D, Nitzan Y, Petcherski S, Bravo E, Habib M, Burkhoff D, Abraham WT. Enhancing Sweat Rate Using a Novel Device for the Treatment of Congestion in Heart Failure. Circ Heart Fail. 2023 Jan;16(1):e009787. doi: 10.1161/CIRCHEARTFAILURE.122.009787. Epub 2022 Nov 2.
- Individual participant dataSharing planned: No
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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.
Doron Aronson, Professor principal investigator
(Director, Inpatient Cardiology Unit (Rambam Health Care Campus)
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 Chronic Heart Failure, 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 10 inclusion and 12 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 1 Nov 2023. 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?
Safety Events (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04578353, which also lists 1 linked publication.
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 1 Nov 2023.