Liver Cirrhosis Clinical Trial
— 2011-AAR-004Official 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
NCT number | NCT01532427 |
Other study ID # | 2011-AAR-004 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2012 |
Est. completion date | July 8, 2019 |
Verified date | October 2020 |
Source | Sequana Medical N.V. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.
Status | Completed |
Enrollment | 100 |
Est. completion date | July 8, 2019 |
Est. primary completion date | July 8, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Uniklinik Dresden | Dresden | |
Germany | Klinikum der Johann Wolfgang Goethe Universität | Frankfurt | |
Germany | Universitätsklinikum des Saarlandes | Homburg/Saar | |
Germany | Universitätsklinikum Jena | Jena | |
Germany | St Georg Klinik | Leipzig | |
Germany | Universitätsklinikum Leipzig, AöR | Leipzig | |
Germany | Medizinische Klinik, Universitätsmedizin Mannheim | Mannheim | |
Germany | Uniklinik Würzburg | Würzburg | |
Spain | Hosptial Universitari Vall d'Hebron | Barcelona | |
Switzerland | Inselspital | Bern | |
Switzerland | University Clinic of Geneva (HUG) | Geneva | |
United Kingdom | The London Clinic, The liver centre | London | |
United Kingdom | Freeman Hospital Newcastle on Tyne | Newcastle on Tyne |
Lead Sponsor | Collaborator |
---|---|
Sequana Medical N.V. |
Germany, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | To monitor the safety of the ALFApump System | 24 months | |
Secondary | clinical performance | To monitor clinical performance of the ALFApump System | 24 months | |
Secondary | clinical impact | To monitor the clinical impact of the ALFApump System | 24 months | |
Secondary | usability | To assess the usability of the ALFApump System | 1 month |
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