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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03200106

Enrollment

Registered

2017-06-27

Start date

2017-08-01

Completion date

2018-03-31

Last updated

2018-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Ascites

Brief summary

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.

Interventions

DEVICEAlfapump

Alfapump implant

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in frequency of LVP after implantation of the alfapump	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

Measure	Time frame	Description
The safety and tolerability of alfapump in patients with malignant ascites	3-6 months post implant	Device, procedure and therapy related AEs and SAEs

Countries

Germany, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026