The Safety and Feasibility of the eLym™ System

Recruiting N/A Interventional Study
Heart; Decompensation, Congestive
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Device Feasibility
Participants needed
70 (estimated)
Sponsor
WhiteSwell, Limited · Industry
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About This Trial
The goal of this feasibility study is to evaluated the safety and performance of the WhiteSwell eLym System in the treatment of fluid overload or congestion in adult patients with Acute Decompensated Heart Failure (ADHF). The main question\[s\] it aims to answer are: * Acute device safety (30 days) * Chronic device safety (31-180 days) * Primary performance Outcomes (Technical success and patient…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Subject is admitted to the hospital with a primary diagnosis of Acute Decompensated Heart Failure (ADHF) 3. Subjects receiving intravenous (IV) diuretic for decompensated heart failure and demonstrating fluid overload. This includes peripheral edema ≥2+ (on …
Contacts

Sergio Shkurovich

+1(818)207-7743

sergio@whiteswell.com

CONTACT