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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01532427
Recruitment Status : Active, not recruiting
First Posted : February 14, 2012
Last Update Posted : April 6, 2018
Information provided by (Responsible Party):
Sequana Medical AG

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

Condition or disease
Liver Cirrhosis Refractory Ascites Malignant Ascites

Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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
Actual Study Start Date : June 2012
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Safety [ Time Frame: 24 months ]
    To monitor the safety of the ALFApump System

Secondary Outcome Measures :
  1. clinical performance [ Time Frame: 24 months ]
    To monitor clinical performance of the ALFApump System

  2. clinical impact [ Time Frame: 24 months ]
    To monitor the clinical impact of the ALFApump System

  3. usability [ Time Frame: 1 month ]
    To assess the usability of the ALFApump System

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The Registry will include 200 patients implanted after market approval at up to 25 centres, in patients with liver cirrhosis or malignancy, with persistent or refractory ascites.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01532427

Uniklinik Dresden
Dresden, Germany
Klinikum der Johann Wolfgang Goethe Universität
Frankfurt, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany, 66421
Universitätsklinikum Jena
Jena, Germany, 07747
St Georg Klinik
Leipzig, Germany, 04129
Universitätsklinikum Leipzig, AöR
Leipzig, Germany
Medizinische Klinik, Universitätsmedizin Mannheim
Mannheim, Germany
Uniklinik Würzburg
Würzburg, Germany
Hosptial Universitari Vall d'Hebron
Barcelona, Spain
Bern, Switzerland, 3010
University Clinic of Geneva (HUG)
Geneva, Switzerland
United Kingdom
The London Clinic, The liver centre
London, United Kingdom
Freeman Hospital Newcastle on Tyne
Newcastle on Tyne, United Kingdom
Sponsors and Collaborators
Sequana Medical AG
Principal Investigator: Andrea De Gottardi, Privatdozent University Hospital Inselspital, Berne

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sequana Medical AG Identifier: NCT01532427     History of Changes
Other Study ID Numbers: 2011-AAR-004
First Posted: February 14, 2012    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

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