Back to resultsEffect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous Patients
Primary Purpose
Chronic Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
The AquaPass System
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring CHF, Edema
Eligibility Criteria
Inclusion Criteria:
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
- 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
Exclusion Criteria:
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
- 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
Sites / Locations
- Rambam Health Care CampusRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AquaPass System
Arm Description
Participants will undergo 3 procedures (each procedure up to 3 (±1) hours operation) using the AquaPass System, with 4-10 days between each procedure.
Outcomes
Primary Outcome Measures
Safety Events
Device related SAE
System Activation
Ability to activate the AquaPass System and control skin temperature to levels between 33°C and 38°C
Treatment Toleration
Subjects can tolerate at least 2 hours of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT04578353
First Posted
September 25, 2020
Last Updated
August 28, 2022
Sponsor
AquaPass Medical Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04578353
Brief Title
Effect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous 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 Healthy Volunteers and Chronic Edematous Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AquaPass Medical Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
CHF, Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AquaPass System
Arm Type
Experimental
Arm Description
Participants will undergo 3 procedures (each procedure up to 3 (±1) hours operation) using the AquaPass System, with 4-10 days between each procedure.
Intervention Type
Device
Intervention Name(s)
The AquaPass System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety Events
Description
Device related SAE
Time Frame
30 days
Title
System Activation
Description
Ability to activate the AquaPass System and control skin temperature to levels between 33°C and 38°C
Time Frame
During procedure
Title
Treatment Toleration
Description
Subjects can tolerate at least 2 hours of treatment
Time Frame
During procedure
Other Pre-specified Outcome Measures:
Title
Skin Changes
Description
Signs of burns grade 1 or more
Time Frame
Before and and immediately after procedure
Title
CBC
Description
Change in Complete Blood Count
Time Frame
Before and and immediately after procedure
Title
NT-proBNP (phase 2 only)
Description
Change in N-terminal prohormone of brain natriuretic peptide levels
Time Frame
Before and and immediately after procedure
Title
Serum creatinine, BUN and Sodium
Description
Change in serum creatinine, blood urea nitrogen (BUN) and sodium levels
Time Frame
Before and and immediately after procedure
Title
Urinary sodium concentration
Description
Change in urinary sodium concentration
Time Frame
Before and and immediately after procedure
Title
Dyspnea
Description
Change in dyspnea score
Time Frame
Before and and immediately after procedure
Title
Pitting edema
Description
Change in pitting edema score
Time Frame
Before and and immediately after procedure
Title
JVD
Description
Change in jugular venous distention (JVD) score
Time Frame
Before and and immediately after procedure
Title
Weight
Description
Changes in weight
Time Frame
During and and immediately after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaakov Nitzan
Phone
+972548005493
Email
yaacov@aquapass-medical.com
First Name & Middle Initial & Last Name or Official Title & Degree
EREZ Hybloom
Phone
+972548885864
Email
erez@aquapass-medical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doron Aronson, Professor
Organizational Affiliation
(Director, Inpatient Cardiology Unit (Rambam Health Care Campus)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doron Aronson, Professor
Phone
+972-4-7772180
Email
d_aronson@rmc.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36321445
Citation
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.
Results Reference
derived
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Effect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous Patients
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