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NCT03973866 · ClinicalTrials.gov registry record · NA
Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)
A NA study, sponsored by Sequana Medical N.V..
- Active
- Registry status
- NA
- Development phase
- 110
- Enrollment target
NCT03973866 is a NA study that is active but no longer recruiting, run by Sequana Medical N.V.. The registered enrollment target is 110 participants.
The verdict
NCT03973866, a NA study, is active but no longer recruiting, sponsored by Sequana Medical N.V..
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
Study Summary
The POSEIDON study is a multi-center, prospective, single arm, crossover pivotal study enrolling up to 70 pivotal cohort patients and up to 45 additional Roll-in patients with refractory or recurrent ascites at up to 20 sites. Pivotal cohort patients will undergo a 3-month pre-implant observation phase after enrollment, followed by implantation of the alfapump and 24 months of post-implant follow up. An analysis will be conducted to support an application for device approval when a minimum of 40 treated pivotal cohort patients are through 6 months.
Interventions
- DEVICE Alfapump
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2024-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03973866
The ClinicalTrials.gov registry entry for NCT03973866 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sequana Medical N.V., which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Alfapump is the first listed.
NCT03973866 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03973866 about?
NCT03973866 is a clinical study titled "Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)". The POSEIDON study is a multi-center, prospective, single arm, crossover pivotal study enrolling up to 70 pivotal cohort patients and up to 45 additional Roll-in patients with refractory or recurrent ascites at up to 20 sites. Pivotal cohort patients will undergo a 3-month pre-implant observation ph...
What is the current status of trial NCT03973866?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 110 participants. The study started on 2019-09-16. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT03973866?
The interventions under investigation include: Alfapump (DEVICE).
Who is sponsoring clinical trial NCT03973866?
This trial is sponsored by Sequana Medical N.V., which has 2 total clinical trials registered on ClinicalTrials.gov.
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