ALFApump System Post Marketing Surveillance Registry
2011-AAR-004
1 other identifier
observational
100
4 countries
13
Brief Summary
This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2012
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2012
CompletedFirst Posted
Study publicly available on registry
February 14, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2019
CompletedOctober 26, 2020
October 1, 2020
7.1 years
February 9, 2012
October 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Safety
To monitor the safety of the ALFApump System
24 months
Secondary Outcomes (3)
clinical performance
24 months
clinical impact
24 months
usability
1 month
Eligibility Criteria
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.
You may qualify if:
- Refractory or recurrent ascites and liver cirrhosis or malignancy
- written informed consent
You may not qualify if:
- \< 18 years
- pregnant
- not able to use the Smart charger
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Uniklinik Dresden
Dresden, Germany
Klinikum der Johann Wolfgang Goethe Universität
Frankfurt, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, 66421, Germany
Universitätsklinikum Jena
Jena, 07747, Germany
St Georg Klinik
Leipzig, 04129, Germany
Universitätsklinikum Leipzig, AöR
Leipzig, Germany
Medizinische Klinik, Universitätsmedizin Mannheim
Mannheim, Germany
Uniklinik Würzburg
Würzburg, Germany
Hosptial Universitari Vall d'Hebron
Barcelona, Spain
Inselspital
Bern, 3010, Switzerland
University Clinic of Geneva (HUG)
Geneva, Switzerland
The London Clinic, The liver centre
London, United Kingdom
Freeman Hospital Newcastle on Tyne
Newcastle upon Tyne, United Kingdom
Related Publications (2)
Stirnimann G, Berg T, Spahr L, Zeuzem S, McPherson S, Lammert F, Storni F, Banz V, Babatz J, Vargas V, Geier A, Engelmann C, Herber A, Trepte C, Capel J, De Gottardi A. Final safety and efficacy results from a 106 real-world patients registry with an ascites-mobilizing pump. Liver Int. 2022 Oct;42(10):2247-2259. doi: 10.1111/liv.15337. Epub 2022 Jul 25.
PMID: 35686702DERIVEDStirnimann G, Berg T, Spahr L, Zeuzem S, McPherson S, Lammert F, Storni F, Banz V, Babatz J, Vargas V, Geier A, Stallmach A, Engelmann C, Trepte C, Capel J, De Gottardi A. Treatment of refractory ascites with an automated low-flow ascites pump in patients with cirrhosis. Aliment Pharmacol Ther. 2017 Nov;46(10):981-991. doi: 10.1111/apt.14331. Epub 2017 Sep 21.
PMID: 28940225DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea De Gottardi, Privatdozent
Insel Gruppe AG, University Hospital Bern
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2012
First Posted
February 14, 2012
Study Start
June 1, 2012
Primary Completion
July 8, 2019
Study Completion
July 8, 2019
Last Updated
October 26, 2020
Record last verified: 2020-10