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Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance — PIONEER  

Ascites Clinical Trial

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 Resistance

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01030185
Study type Interventional
Source NovaShunt AG
Contact
Status Completed
Phase Phase 2/Phase 3
Start date February 2010
Completion date June 2013
View Details
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