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: June 18, 2014
Last verified: June 2014

February 9, 2012
June 18, 2014
June 2012
December 2015   (final data collection date for primary outcome measure)
Safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
To monitor the safety of the ALFApump System
Safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
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 ] [ 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
  • Clinical performance [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To monitor the clinical performance of the ALFApump System by monitoring ascites transport and the requirement for paracentesis.
  • clinical performance [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To monitor clinical performance of the ALFApump System by analysis of downloaded "logfiles
  • clinical impact [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To monitor the clinical impact of the ALFApump System by monitoring patient's clinical status, clinical chemistry and haematology.
  • usability [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
December 2016
December 2015   (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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   Spain,   Switzerland,   Germany
 
NCT01532427
2011-AAR-004
No
Sequana Medical AG
Sequana Medical AG
Not Provided
Principal Investigator: Andrea De Gottardi, Privatdozent University Hospital Inselspital, Berne
Sequana Medical AG
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP