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ALFApump System Post Marketing Surveillance Registry (2011-AAR-004)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Sequana Medical AG
ClinicalTrials.gov Identifier:
NCT01532427
First received: February 9, 2012
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition
Liver Cirrhosis
Refractory Ascites

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 and With Persistent and Refractory Ascites

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Sequana Medical AG:

Primary Outcome Measures:
  • Safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    To monitor the safety of the ALFApump System


Secondary Outcome Measures:
  • clinical performance [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To monitor clinical performance of the ALFApump System

  • clinical impact [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To monitor the clinical impact of the ALFApump System

  • usability [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    To assess the usability of the ALFApump System


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The Registry will include at least 100 of the first patients implanted after market approval at up to 25 centres, in patients with refractory or recurrent ascites and liver cirrhosis.

Criteria

Inclusion Criteria:

  • Refractory or recurrent ascites and liver cirrhosis
  • written informed consent

Exclusion Criteria:

  • < 18 years
  • pregnant
  • not able to use the Smart charger
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532427

Locations
Germany
Klinikum der Johann Wolfgang Goethe Universität
Frankfurt, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany, 66421
Universitätsklinikum Leipzig, AöR
Leipzig, Germany
Medizinische Klinik, Universitätsmedizin Mannheim
Mannheim, Germany
Spain
Hosptial Universitari Vall d'Hebron
Barcelona, Spain
Switzerland
Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
Sequana Medical AG
Investigators
Principal Investigator: Andrea De Gottardi, Privatdozent University Hospital Inselspital, Berne
  More Information

No publications provided

Responsible Party: Sequana Medical AG
ClinicalTrials.gov Identifier: NCT01532427     History of Changes
Other Study ID Numbers: 2011-AAR-004
Study First Received: February 9, 2012
Last Updated: April 30, 2013
Health Authority: Switzerland: Ethikkommission
Germany: Ethics Commission
United Kingdom: National Health Service
Spain: Ethics Committee

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
 Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013