Clinical Trial: Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Multi-center, Open Label, Non-randomized Study to Investigate the Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic
Brief Summary:
To investigate the safety and performance of the Automated Fluid Shunt in patients with ascites and diuretic resistance.
Study Size and Duration The primary study population will include 40 patients enrolled and implanted with the NovaShunt Automated Fluid Shunt (AFS) in up to 15 centers in Europe.
Detailed Summary:
Sponsor: NovaShunt AG
Current Primary Outcome: The safety of the NovaShunt AFS will be evaluated by the incidence and severity of device- and procedure-related serious adverse events [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Paracentesis requirements [ Time Frame: 6 month ]
- Hematology [ Time Frame: 6 month ]
- Incidence of hemodynamic instability [ Time Frame: 6 month ]
- Incidence and severity of peripheral edema [ Time Frame: 6 month ]
- Patient Quality of Life. [ Time Frame: 6 month ]
Original Secondary Outcome: Paracentesis requirements, Nutritional Status, Hematology, chemistry, anticoagulation and urinalysis parameter status, Incidence of hemodynamic instability, Incidence and severity of peripheral edema, Patient Quality of Life. [ Time Frame: 6 month ]
Information By: NovaShunt AG
Dates:
Date Received: December 10, 2009
Date Started: February 2010
Date Completion:
Last Updated: September 5, 2013
Last Verified: September 2013
