Clinical trial NCT01532427: ALFApump System Post Marketing Surveillance Registry
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Refractory Ascites
Malignant Ascites
Lead sponsor: Sequana Medical N.V.
Sponsor class: INDUSTRY
First posted: 2012-02-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: 24 months
Secondary outcomes:
measure: clinical performance
timeFrame: 24 months
measure: clinical impact
timeFrame: 24 months
measure: usability
timeFrame: 1 month
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Uniklinik Dresden
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe Universität
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Leipzig
country: Germany
facility: St Georg Klinik
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, AöR
city: Mannheim
country: Germany
facility: Medizinische Klinik, Universitätsmedizin Mannheim
city: Würzburg
country: Germany
facility: Uniklinik Würzburg
city: Barcelona
country: Spain
facility: Hosptial Universitari Vall d'Hebron
city: Bern
country: Switzerland
facility: Inselspital
city: Geneva
country: Switzerland
facility: University Clinic of Geneva (HUG)
city: London
country: United Kingdom
facility: The London Clinic, The liver centre
city: Newcastle on Tyne
country: United Kingdom
facility: Freeman Hospital Newcastle on Tyne
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Andrea De Gottardi, Privatdozent
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Stirnimann 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.