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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01532427
First Posted: February 14, 2012
Last Update Posted: June 14, 2017
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.
Information provided by (Responsible Party):
Sequana Medical AG
February 9, 2012
February 14, 2012
June 14, 2017
June 2012
August 2017   (Final data collection date for primary outcome measure)
Safety [ Time Frame: 24 months ]
To monitor the safety of the ALFApump System
Safety [ Time Frame: 24 months ]
To monitor the safety of the ALFApump System by collecting and reviewing all serious adverse device effects and device deficiencies.
Complete list of historical versions of study NCT01532427 on ClinicalTrials.gov Archive Site
  • clinical performance [ Time Frame: 24 months ]
    To monitor clinical performance of the ALFApump System
  • clinical impact [ Time Frame: 24 months ]
    To monitor the clinical impact of the ALFApump System
  • usability [ Time Frame: 1 month ]
    To assess the usability of the ALFApump System
  • Clinical performance [ Time Frame: 24 months ]
    To monitor the clinical performance of the ALFApump System by monitoring ascites transport and the requirement for paracentesis.
  • clinical performance [ Time Frame: 24 months ]
    To monitor clinical performance of the ALFApump System by analysis of downloaded "logfiles
  • clinical impact [ Time Frame: 24 months ]
    To monitor the clinical impact of the ALFApump System by monitoring patient's clinical status, clinical chemistry and haematology.
  • usability [ Time Frame: 1 month ]
    To assess the usability of the ALFApump System through clinician and patient questionnaires
Not Provided
Not Provided
 
ALFApump System Post Marketing Surveillance Registry
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
This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.
Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
2 Years
Not Provided
Non-Probability Sample
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.
  • Liver Cirrhosis
  • Refractory Ascites
  • Malignant Ascites
Not Provided
Not Provided
Not Provided
 
Active, not recruiting
100
August 2017
August 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Spain,   Switzerland,   United Kingdom
 
 
NCT01532427
2011-AAR-004
No
Not Provided
Not Provided
Sequana Medical AG
Sequana Medical AG
Not Provided
Principal Investigator: Andrea De Gottardi, Privatdozent University Hospital Inselspital, Berne
Sequana Medical AG
June 2017