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

NCT01030185 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-09-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • NovaShunt AG

    lead INDUSTRY

Principal Investigators

  • Jose Such, MD · Hospital General Uneversitario de Alicante C/ Maestro Alonso 109 - 03010 Alicante /Alacant, Spain

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-11-30
Completion
2013-06-30

Countries

  • Belgium
  • Bulgaria
  • Germany
  • Spain

Study Locations

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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 NCT01030185 on ClinicalTrials.gov