NCT01030185

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: NovaShunt AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ascites

Interventions

Type	Name	Description
DEVICE	NovaShunt's Automated Fluid Shunt implantation	The Automated Fluid Shunt (AFS) Device consists of an implantable sealed housing which contains an internally powered pump with supportive electronic components and circuits, an implantable Peritoneal Catheter, implantable Bladder Catheter and a non-implantable Charger used for wireless recharging an AFS battery and collecting data from the Device.

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-11-01
• Completion: 2013-06-01
• First posted: 2009-12-11
• Last updated: 2013-09-06

Locations

9 sites across 4 countries: Belgium, Bulgaria, Germany, Spain