Retrospective Study in the Use of the Alfapump and the Treatment of Malignant Ascites

N/ACompletedNCT03200106

Sequana Medical N.V.17 enrolled

Overview

Treatment of malignant ascites with the alfapump offers a new treatment option for this patient group. So far, there is no systematic analysis of patients with this indication available in the literature. This retrospective analysis offers the possibility to assemble already existing data within a reasonably short time frame. Based on this analysis, a prospective analysis can be designed.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Malignant Ascites

Interventions

AlfapumpDEVICE

Alfapump implant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with malignant ascites * Patients with alfapump implanted for malignant ascites * Patients 18 years or older at the time of death Exclusion Criteria: * Patient is alive at the time of inclusion assessment

Locations (3)

Universitätsklinikum Leipzig

Leipzig, Germany

Inselspital

Bern, Switzerland

Hammersmith Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Change in frequency of LVP after implantation of the alfapump

The primary objective of the study is to evaluate the performance of the alfapump in reducing the need for large volume paracentesis (LVP) defined as paracentesis of five or more litres of ascites and not by pump paracentesis.

Time frame: 3-6 months post implant

Secondary Outcomes

The safety and tolerability of alfapump in patients with malignant ascites

Device, procedure and therapy related AEs and SAEs

Time frame: 3-6 months post implant

Data from ClinicalTrials.gov

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