Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401109
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-05-02
Brief Title:
Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients a European Registry
Sponsor:
AquaPass Medical Ltd
Organization:
AquaPass Medical Ltd
Study Overview
Official Title:
Evaluating the Safety and Efficacy of the AquaPass System a Renal-independent Fluid Removal System in ADHF Patients Suffering From Fluid Overload a European Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REFORM-HF II
Brief Summary:
The AquaPass is a non-invasive renal-intended system designed to enhance fluid transfer through the skin by increasing sweat rate to treat fluid overload in heart failure patients
This study will further evaluate the safety efficacy and usability of the AquaPass system in the hospital and home settings
This study will further evaluate the safety efficacy and usability of the AquaPass system in the hospital and home settings
Detailed Description:
The AquaPass system is non-invasive and functions independently of the renal system targeting the direct removal of fluids directly from the interstitial compartment through the skin by activating the eccrine sweat glands
The patient wears a component that is connected to a control unit which induces warm air to create a controlled environment around the skin stimulating sweat production The sweat evaporates instantly ensuring that the patient remains dry and comfortable
In this study the investigators would like to further investigate the efficacy of the system when used in hospital settings in patients hospitalized for decompensated heart failure and fluid overload and to continue the treatment in their homes immediately after the hospitalization for another 30 days
The patient wears a component that is connected to a control unit which induces warm air to create a controlled environment around the skin stimulating sweat production The sweat evaporates instantly ensuring that the patient remains dry and comfortable
In this study the investigators would like to further investigate the efficacy of the system when used in hospital settings in patients hospitalized for decompensated heart failure and fluid overload and to continue the treatment in their homes immediately after the hospitalization for another 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None