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OpenTrials
Completed

NCT Number: NCT01532427

ALFApump System Post Marketing Surveillance Registry

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

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Key information

Conditions

Liver Cirrhosis Ascites Digestive System Diseases Fibrosis Liver Diseases Malignant Ascites Pathologic Processes Pathological Conditions, Signs and Symptoms Refractory Ascites

Sex eligibility

All sexes

Study type

Observational

Primary location

Uniklinik Dresden, Dresden, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Safety

    Time frame: 24 months

    To monitor the safety of the ALFApump System

Secondary outcomes

  1. clinical performance

    Time frame: 24 months

    To monitor clinical performance of the ALFApump System

  2. clinical impact

    Time frame: 24 months

    To monitor the clinical impact of the ALFApump System

  3. usability

    Time frame: 1 month

    To assess the usability of the ALFApump System

Sponsors and collaborators

Lead sponsor

Sequana Medical N.V.

Industry

Registry information

Official study 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

Acronym: 2011-AAR-004

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Feb 14, 2012
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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