ALFApump System Post Marketing Surveillance Registry

N/ACompletedNCT01532427

Sequana Medical N.V.100 enrolled

Overview

This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Liver Cirrhosis Refractory Ascites Malignant Ascites

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Refractory or recurrent ascites and liver cirrhosis or malignancy * written informed consent Exclusion Criteria: * \< 18 years * pregnant * not able to use the Smart charger

Locations (13)

Uniklinik Dresden

Dresden, Germany

Klinikum der Johann Wolfgang Goethe Universität

Frankfurt, Germany

Universitätsklinikum des Saarlandes

Homburg/Saar, Germany

Outcomes

Primary Outcomes

Safety

To monitor the safety of the ALFApump System

Time frame: 24 months

Secondary Outcomes

clinical performance

To monitor clinical performance of the ALFApump System

Time frame: 24 months

clinical impact

To monitor the clinical impact of the ALFApump System

Time frame: 24 months

usability

To assess the usability of the ALFApump System

Time frame: 1 month

Data from ClinicalTrials.gov

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