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Safety and Feasibility of the WhiteSwell System"

NCT02863796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-04-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • WhiteSwell, Limited

    lead INDUSTRY

Principal Investigators

  • William T. Abraham, MD · Ohio State University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2019-04-24
Completion
2022-03-14
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02863796 on ClinicalTrials.gov