Trials / Completed
CompletedNCT04578353
Effect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous Patients
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- AquaPass Medical Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-01-28
- Primary completion
- 2022-02-12
- Completion
- 2022-06-12
- First posted
- 2020-10-08
- Last updated
- 2023-11-01
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT04578353. Inclusion in this directory is not an endorsement.