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Effect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04578353
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
AquaPass Medical Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Device: The AquaPass System Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 23, 2020
Estimated Primary Completion Date : February 12, 2022
Estimated Study Completion Date : June 12, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: AquaPass System
Participants will undergo 3 procedures (each procedure up to 3 (±1) hours operation) using the AquaPass System, with 4-10 days between each procedure.
 Device: The AquaPass System
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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety Events [ Time Frame: 30 days ]
    Device related SAE

  2. System Activation [ Time Frame: During procedure ]
    Ability to activate the AquaPass System and control skin temperature to levels between 33°C and 38°C

  3. Treatment Toleration [ Time Frame: During procedure ]
    Subjects can tolerate at least 2 hours of treatment


Other Outcome Measures:
  1. Skin Changes [ Time Frame: Before and and immediately after procedure ]
    Signs of burns grade 1 or more

  2. CBC [ Time Frame: Before and and immediately after procedure ]
    Change in Complete Blood Count

  3. NT-proBNP (phase 2 only) [ Time Frame: Before and and immediately after procedure ]
    Change in N-terminal prohormone of brain natriuretic peptide levels

  4. Serum creatinine, BUN and Sodium [ Time Frame: Before and and immediately after procedure ]
    Change in serum creatinine, blood urea nitrogen (BUN) and sodium levels

  5. Urinary sodium concentration [ Time Frame: Before and and immediately after procedure ]
    Change in urinary sodium concentration

  6. Dyspnea [ Time Frame: Before and and immediately after procedure ]
    Change in dyspnea score

  7. Pitting edema [ Time Frame: Before and and immediately after procedure ]
    Change in pitting edema score

  8. JVD [ Time Frame: Before and and immediately after procedure ]
    Change in jugular venous distention (JVD) score

  9. Weight [ Time Frame: During and and immediately after procedure ]
    Changes in weight


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Phase 1: Healthy subjects:

  1. Age ≥ 18
  2. Subject has been informed on the nature of the study and has provided informed consent
  3. Subject is capable of meeting study requirements

Phase 2: CHF Patients:

  1. Age ≥ 18 and diagnosed with CHF
  2. Subject has 2 or more score for pitting edema
  3. Subject is taking diuretic medications at home
  4. Subject has been informed on the nature of the study and has provided informed consent
  5. Subject is capable of meeting study requirements

Exclusion Criteria:

Phase 1: Healthy subjects:

  1. Subject is enrolled to another clinical investigation that might interfere with this study
  2. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
  3. Subject has no known sensitivity to Neoprene

Phase 2: CHF Patients:

  1. Subject is enrolled to another clinical investigation that might interfere with this study
  2. Subject is admitted to the hospital for acute decompensated or acute heart failure
  3. Subject has any known lower body skin problems (open wounds, ulcers)
  4. eGFR<15 ml/min/m2
  5. Subject with severe peripheral arterial disease
  6. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
  7. Subject has known sensitivity to Neoprene
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04578353


Contacts
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Contact: Yaakov Nitzan +972548005493 yaacov@aquapass-medical.com
Contact: EREZ Hybloom +972548885864 erez@aquapass-medical.com

Locations
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Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 3109601
Contact: Doron Aronson, Professor    +972-4-7772180    d_aronson@rmc.gov.il   
Sponsors and Collaborators
AquaPass Medical Ltd.
Investigators
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Principal Investigator: Doron Aronson, Professor (Director, Inpatient Cardiology Unit (Rambam Health Care Campus)
More Information
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Responsible Party: AquaPass Medical Ltd.
ClinicalTrials.gov Identifier: NCT04578353    
Other Study ID Numbers: CL-003-01
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AquaPass Medical Ltd.:
CHF
Edema
Additional relevant MeSH terms:
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Heart Failure
Edema
Heart Diseases
Cardiovascular Diseases