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

NCT03973866 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-12-01

No results posted yet for this 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.

Conditions

  • Ascites

Interventions

DEVICE

Alfapump

Implantation of alfapump

Sponsors & Collaborators

  • Sequana Medical N.V.

    lead INDUSTRY

Principal Investigators

  • Florence Wong, MD · Toronto General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-16
Primary Completion
2024-03-30
Completion
2024-06-30
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03973866 on ClinicalTrials.gov