Retrospective Study in the Use of the Alfapump and the Treatment of Malignant Ascites
- Conditions
- Malignant Ascites
- Registration Number
- NCT03200106
- Lead Sponsor
- Sequana Medical N.V.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- Patients with malignant ascites
- Patients with alfapump implanted for malignant ascites
- Patients 18 years or older at the time of death
- Patient is alive at the time of inclusion assessment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The safety and tolerability of alfapump in patients with malignant ascites 3-6 months post implant Device, procedure and therapy related AEs and SAEs
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (3)
Hammersmith Hospital
🇬🇧London, United Kingdom
Inselspital
🇨🇭Bern, Switzerland
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany