Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)
← catalyst calendarSponsored by Sequana Medical N.V. (industry) · SEQUA.BR — their whole pipeline →.
Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
110actual
Sites
15
Countries
Canada, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-09-16 | actual | When the study began enrolling |
| Primary completion | 2024-03-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2024-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2019-06-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2022-12-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Ascites
Intervention
- Device: Alfapump
Primary outcomes
what the primary-completion date above is the date OFPer-patient ratio of post-implant to pre-implant with respect to average monthly number of therapeutic paracentesis
measured Comparing data from the post-implant 3-month observation period to data from the pre-implant 3-month observation period:
Proportion of patients with at least 50% reduction in number of therapeutic paracenteses from the pre-observation period to post-observation period
measured Comparing data from the post-implant 3-month observation period to data from the pre-implant 3-month observation period
Combined rate of open surgical reintervention due to pump system related adverse event or to restore pump functionality, pump explant due to pump system related adverse event, or pump system related death
measured from time of pump implant through 6 months post-implant
Publications
- PMID 39760647 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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