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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfapump | Device | Alfapump implant |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-6 months post implant |
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability of alfapump in patients with malignant ascites | Device, procedure and therapy related AEs and SAEs | 3-6 months post implant |
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Inclusion Criteria:
Exclusion Criteria:
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A total of up to 20 patients' charts who have previously been treated with alfapump will be reviewed.
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| Name | Affiliation | Role |
|---|---|---|
| Jeroen Capel, MSc | Sequana Medical | Study Director |
| Christina Fotopoulou, Ph.D | Hammersmith Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Leipzig | Leipzig | 04103 | Germany | |||
| Inselspital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31805921 | Derived | Fotopoulou C, Berg T, Hausen A, Hennig R, Jalan R, Malago M, Capel J, De Gottardi A, Stirnimann G. Continuous low flow ascites drainage through the urinary bladder via the Alfapump system in palliative patients with malignant ascites. BMC Palliat Care. 2019 Dec 5;18(1):109. doi: 10.1186/s12904-019-0497-3. |
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| Bern |
| 3010 |
| Switzerland |
| Hammersmith Hospital | London | W120HS | United Kingdom |