Nuwellis

Country

Ownership: -

Employees: 59

Market Cap: -

Website

Introduction: Nuwellis, Inc. operates as a medical device company. It engages in the provision of products for the treatment of fluid overload. The firm's products include Aquadex FlexFlow System, which provides an ultrafiltration for the removal of salt and water in patients with hypervolemia, or fluid overload. It operates through Cardiac and Coronary Disease Products segment. The company was founded by Crispin Marsh and William S. Peters in November 1999 and is headquartered in Eden Prairie, MN.

Clinical Trials

Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

Not Applicable

Recruiting

Conditions: Heart Failure (for Example, Fluid Overload)
Heart Failure
Fluid Overload

Interventions: Device: Aquadex Smartflow® System
Drug: IV Loop Diuretics

First Posted Date: 2022-04-08

Last Posted Date: 2025-05-15

Lead Sponsor: Nuwellis, Inc.

Target Recruit Count: 372

Registration Number: NCT05318105

Locations: 🇺🇸
Sharp Memorial Hospital, San Diego Cardiac Center, San Diego, California, United States
🇺🇸
The Christ Hospital, Cincinnati, Ohio, United States
🇺🇸
Banner Health, Tucson, Arizona, United States

and more 14 locations

Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)

Terminated

Conditions: Fluid Overload

Interventions: Device: Aquadex™ System

First Posted Date: 2020-11-25

Last Posted Date: 2024-02-20

Lead Sponsor: Nuwellis, Inc.

Target Recruit Count: 97

Registration Number: NCT04644731

Locations: 🇺🇸
Lucile Packard Children's Hospital Stanford, Palo Alto, California, United States
🇺🇸
Le Bonheur Children's Hospital, Memphis, Tennessee, United States
🇺🇸
Children's of Alabama Hospital, Birmingham, Alabama, United States

and more 4 locations

A Feasibility Study on Ultrafiltration and Blood Volume Measurements

Not Applicable

Terminated

Conditions: Acute Decompensated Heart Failure
Fluid Overload

Interventions: Device: Aquadex FlexFlow System and BVA-100

First Posted Date: 2020-01-27

Last Posted Date: 2024-11-14

Lead Sponsor: Nuwellis, Inc.

Target Recruit Count: 6

Registration Number: NCT04241718

Locations: 🇺🇸
Midwest Cardiovascular Institute, Naperville, Illinois, United States

C-Pulse® System European Multicenter Study

Completed

Conditions: Heart Failure

First Posted Date: 2013-06-07

Last Posted Date: 2023-08-08

Lead Sponsor: Nuwellis, Inc.

Target Recruit Count: 15

Registration Number: NCT01872949

Locations: 🇩🇪
Unfallkrankenhaus, Berlin, Germany
🇩🇪
Universität Tübingen, Tübingen, Germany
🇩🇪
Cardio-Centrum Berlin, Berlin, Germany

and more 5 locations

C-Pulse® System: A Heart Assist Device Clinical Study

Not Applicable

Terminated

Conditions: Heart Failure

Interventions: Device: C-Pulse® System Counterpulsation

First Posted Date: 2012-12-04

Last Posted Date: 2024-01-11

Lead Sponsor: Nuwellis, Inc.

Target Recruit Count: 38

Registration Number: NCT01740596

Locations: 🇺🇸
Temple University, Philadelphia, Pennsylvania, United States
🇺🇸
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
The Ohio State University Medical Center, Columbus, Ohio, United States

and more 25 locations

Study of Heart Failure Hospitalizations After Aquapheresis Therapy Compared to Intravenous (IV) Diuretic Treatment

Not Applicable

Terminated

Conditions: Heart Failure
Acute Decompensated Heart Failure (ADHF)
Cardiac Failure

Interventions: Drug: IV Loop Diuretics (LD)
Device: Isolated veno-venous ultrafiltration (AQ)

First Posted Date: 2011-11-18

Last Posted Date: 2023-08-29

Lead Sponsor: Nuwellis, Inc.

Target Recruit Count: 224

Registration Number: NCT01474200

Locations: 🇺🇸
Elkhart General HealthCare, Elkhart, Indiana, United States
🇺🇸
Drexel University College of Medicine, Philadelphia, Pennsylvania, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

and more 35 locations

C-Pulse Implantable Counterpulsation Pump (ICP) - A Heart Assist Device

Not Applicable

Terminated

Conditions: Heart Failure

Interventions: Device: C-Pulse™ (Implantable Counterpulsation Therapy)

First Posted Date: 2010-08-06

Last Posted Date: 2023-08-15

Lead Sponsor: Nuwellis, Inc.

Target Recruit Count: 3

Registration Number: NCT01176370

Locations: 🇨🇦
McGill University Health Centre - Royal Victoria Hospital, Montreal, Quebec, Canada

C-Pulse IDE Feasibility Study- A Heart Assist System

Not Applicable

Completed

Conditions: Heart Failure

Interventions: Device: C-Pulse™ (Implantable Counterpulsation Therapy)

First Posted Date: 2008-12-31

Last Posted Date: 2023-08-24

Lead Sponsor: Nuwellis, Inc.

Target Recruit Count: 21

Registration Number: NCT00815880

Locations: 🇺🇸
University of Louisville, Louisville, Kentucky, United States
🇺🇸
St. Paul Heart Clinic, Saint Paul, Minnesota, United States
🇺🇸
Ohio State University, Columbus, Ohio, United States

and more 3 locations

Ultrafiltration Versus Intravenous (IV) Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: (UNLOAD)

Not Applicable

Completed

Conditions: Congestive Heart Failure

First Posted Date: 2005-07-27

Last Posted Date: 2007-03-15

Lead Sponsor: Nuwellis, Inc.

Target Recruit Count: 200

Registration Number: NCT00124137

Locations: 🇺🇸
Midwest Heart Institute, Lombard, Illinois, United States

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