ALFApump System Post Marketing Surveillance Registry

NCT ID: NCT01532427

Last Updated: 2020-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2019-07-08

Brief Summary

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

Detailed Description

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Conditions

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Liver Cirrhosis Refractory Ascites Malignant Ascites

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sequana Medical N.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea De Gottardi, Privatdozent

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

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Uniklinik Dresden

Dresden, , Germany

Site Status

Klinikum der Johann Wolfgang Goethe Universität

Frankfurt, , Germany

Site Status

Universitätsklinikum des Saarlandes

Homburg/Saar, , Germany

Site Status

Universitätsklinikum Jena

Jena, , Germany

Site Status

St Georg Klinik

Leipzig, , Germany

Site Status

Universitätsklinikum Leipzig, AöR

Leipzig, , Germany

Site Status

Medizinische Klinik, Universitätsmedizin Mannheim

Mannheim, , Germany

Site Status

Uniklinik Würzburg

Würzburg, , Germany

Site Status

Hosptial Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Inselspital

Bern, , Switzerland

Site Status

University Clinic of Geneva (HUG)

Geneva, , Switzerland

Site Status

The London Clinic, The liver centre

London, , United Kingdom

Site Status

Freeman Hospital Newcastle on Tyne

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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Germany Spain Switzerland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35686702 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28940225 (View on PubMed)

Other Identifiers

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2011-AAR-004

Identifier Type: -

Identifier Source: org_study_id