ALFApump System Post Marketing Surveillance Registry (2011-AAR-004)

October 23, 2020 updated by: Sequana Medical N.V.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany
        • Uniklinik Dresden
      • Frankfurt, Germany
        • Klinikum Der Johann Wolfgang Goethe Universitat
      • Homburg/Saar, Germany, 66421
        • Universitätsklinikum des Saarlandes
      • Jena, Germany, 07747
        • Universitatsklinikum Jena
      • Leipzig, Germany, 04129
        • St Georg Klinik
      • Leipzig, Germany
        • Universitatsklinikum Leipzig, AoR
      • Mannheim, Germany
        • Medizinische Klinik, Universitätsmedizin Mannheim
      • Würzburg, Germany
        • Uniklinik Würzburg
  • Spain
      • Barcelona, Spain
        • Hosptial Universitari Vall d'Hebron
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital
      • Geneva, Switzerland
        • University Clinic of Geneva (HUG)
  • United Kingdom
      • London, United Kingdom
        • The London Clinic, The liver centre
      • Newcastle on Tyne, United Kingdom
        • Freeman Hospital Newcastle on Tyne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 24 months
To monitor the safety of the ALFApump System
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical performance
Time Frame: 24 months
To monitor clinical performance of the ALFApump System
24 months
clinical impact
Time Frame: 24 months
To monitor the clinical impact of the ALFApump System
24 months
usability
Time Frame: 1 month
To assess the usability of the ALFApump System
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sequana Medical N.V.

Investigators

  • Principal Investigator: Andrea De Gottardi, Privatdozent, University Hospital Inselspital, Berne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

July 8, 2019

Study Completion (Actual)

July 8, 2019

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 13, 2012

First Posted (Estimate)

February 14, 2012

Study Record Updates

Last Update Posted (Actual)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 23, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-AAR-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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