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

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.

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Key information

Conditions

Malignant Ascites

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Leipzig, Leipzig, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alfapump

Device

Alfapump implant

Primary outcomes

Change in frequency of LVP after implantation of the alfapump

Time frame: 3-6 months post implant

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.

Secondary outcomes

The safety and tolerability of alfapump in patients with malignant ascites

Time frame: 3-6 months post implant

Device, procedure and therapy related AEs and SAEs

Sponsors and collaborators

Lead sponsor

Sequana Medical N.V.

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Jun 27, 2017
Registry last updated: Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed