Clinical trial · Observational
ALFApump System Post Marketing Surveillance Registry
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
NCT01532427CI-TRIAL-000479102011-AAR-004completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cirrhosis | — | UNRESOLVED | — |
| Malignant Ascites | — | UNRESOLVED | — |
| Refractory Ascites | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety
- timeFrame
- 24 months
- description
- To monitor the safety of the ALFApump System
Secondary outcomes (3)
- measure
- clinical performance
- timeFrame
- 24 months
- description
- To monitor clinical performance of the ALFApump System
- measure
- clinical impact
- timeFrame
- 24 months
- description
- To monitor the clinical impact of the ALFApump System
- measure
- usability
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDStirnimann 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 35686702
- DERIVEDStirnimann 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 28940225