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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


N/A
N/A
N/A
Open (Enrolling by invite only)
Both
Liver Cirrhosis, Refractory Ascites

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Trial Information

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


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

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Safety

Outcome Description:

To monitor the safety of the ALFApump System

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

Andrea De Gottardi, Privatdozent

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Inselspital, Berne

Authority:

Switzerland: Ethikkommission

Study ID:

2011-AAR-004

NCT ID:

NCT01532427

Start Date:

June 2012

Completion Date:

March 2016

Related Keywords:

  • Liver Cirrhosis
  • Refractory Ascites
  • Ascites
  • Liver Cirrhosis
  • Fibrosis

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