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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: Active NA study, sponsored by Sequana Medical N.V..

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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Defined as removal of ascites ≥1.5L through needle puncture of abdominal wall

Interventions

  • DEVICE Alfapump

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2019-09-16
Est. Completion 2024-06-30
Phase NA
Sequana Medical N.V.

2 total trials

What the registry record for NCT03973866 still lists

NCT03973866 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Alfapump is the first listed.

NCT03973866 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03973866's enrollment target sits among peer trials

110 816th of 2000 higher than 1,176 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03973866, the US trial registry maintained by the National Library of Medicine. NCT03973866 (mid enrollment · none site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.