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Active, not recruiting Not applicable Interventional

Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)

ClinicalTrials.gov ID: NCT03973866

Public ClinicalTrials.gov record NCT03973866. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 6:08 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Alfapump® System in the Treatment of Refractory or Recurrent Ascites: a Multicenter Single Arm Within Subject Crossover Design Pivotal Study (the POSEIDON Study)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03973866
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Sequana Medical N.V.
Industry
Enrollment
110 participants

Conditions and interventions

Conditions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 16, 2019 (Actual)
Primary completion
Mar 30, 2024 (Estimated)
Completion
Jun 30, 2024 (Estimated)
Last update posted
Dec 1, 2022

2019 – 2024

United States locations

U.S. sites
13
U.S. states
11
U.S. cities
12
Facility City State ZIP Site status
Mayo Clinic (Arizona) Phoenix Arizona 85054 —
Cedars-Sinai Comprehensive Transplant Center Los Angeles California 90048 —
University of Massachusetts Memorial Medical Center Worcester Massachusetts 01605 —
University of Minnesota Minneapolis Minnesota 55455 —
Mayo Clinic Rochester Minnesota 55905 —
Duke University Durham North Carolina 27705 —
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104 —
Medical University of South Carolina Charleston South Carolina 29425 —
Avera Medical Group Sioux Falls South Dakota 57105 —
Methodist Dallas Dallas Texas 75203 —
Baylor University Medical Center (Dallas) Dallas Texas 75246 —
McGuire VA Medical Center Richmond Virginia 23249 —
Medical College of Wisconsin (Froedtert) Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03973866, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 1, 2022 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03973866 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →