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NCT01532427 Clinical Trial

ALFApump System Post Marketing Surveillance Registry

Liver Cirrhosis Clinical Trial

— 2011-AAR-004  

Official title:
ALFApump System Post Marketing Surveillance Registry, In Support of the Following Indication: Automated Removal of Excess Peritoneal Fluid Into the Urinary Bladder in Patients With Cirrhosis or Malignancy, With Persistent or Refractory Ascites

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01532427
Other study ID # 2011-AAR-004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2012
Est. completion date July 8, 2019

Study information
Verified date October 2020
Source Sequana Medical N.V.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date July 8, 2019
Est. primary completion date July 8, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Uniklinik Dresden Dresden
Germany Klinikum der Johann Wolfgang Goethe Universität Frankfurt
Germany Universitätsklinikum des Saarlandes Homburg/Saar
Germany Universitätsklinikum Jena Jena
Germany St Georg Klinik Leipzig
Germany Universitätsklinikum Leipzig, AöR Leipzig
Germany Medizinische Klinik, Universitätsmedizin Mannheim Mannheim
Germany Uniklinik Würzburg Würzburg
Spain Hosptial Universitari Vall d'Hebron Barcelona
Switzerland Inselspital Bern
Switzerland University Clinic of Geneva (HUG) Geneva
United Kingdom The London Clinic, The liver centre London
United Kingdom Freeman Hospital Newcastle on Tyne Newcastle on Tyne

Sponsors (1)
Lead Sponsor Collaborator
Sequana Medical N.V.

Countries where clinical trial is conducted

Germany,  Spain,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety To monitor the safety of the ALFApump System 24 months
Secondary clinical performance To monitor clinical performance of the ALFApump System 24 months
Secondary clinical impact To monitor the clinical impact of the ALFApump System 24 months
Secondary usability To assess the usability of the ALFApump System 1 month
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