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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: June 18, 2014
Last verified: June 2014
  Purpose

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


Condition
Liver Cirrhosis
Refractory Ascites
Malignant Ascites

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


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: 200
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 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 200 patients implanted after market approval at up to 25 centres, in patients with liver cirrhosis or malignancy, with persistent or refractory ascites.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532427

Locations
Germany
Uniklinik Dresden
Dresden, 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
Uniklinik Würzburg
Würzburg, Germany
Spain
Hosptial Universitari Vall d'Hebron
Barcelona, Spain
Switzerland
Inselspital
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
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: June 18, 2014
Health Authority: Switzerland: Ethikkommission
Germany: Ethics Commission
United Kingdom: National Health Service
Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014