NCT02863796

Safety and Feasibility of the WhiteSwell System"

The Safety and Feasibility of the WhiteSwell System for the Reduction of Interstitial Fluid Overload in Patients With Acutely Decompensated Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: WhiteSwell, Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Early feasibility study to evaluate safety and performance of the WhiteSwell System in the treatment of fluid overload in hospitalized patients with acutely decompensated heart failure.

Detailed description

This study will evaluate the safety and feasibility of the WhiteSwell System for the treatment of patients hospitalized with acutely decompensated heart failure. Subjects who have been admitted to the hospital less than 72 hours for ADHF will be evaluated for inclusion into the study.

Conditions

• Heart Failure
• Congestive Heart Failure

Interventions

Type	Name	Description
DEVICE	WhiteSwell System	To promote movement of interstitial fluid to the intravascular space to allow for the body to remove it, in conjunction with a diuresis regimen.

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-04-24
• Completion: 2022-03-14
• First posted: 2016-08-11
• Last updated: 2022-04-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study