ALFAPUMP SYSTEM IN THE TREATMENT OF REFRACTORY OR RECURRENT ASCITES: A MULTICENTER SINGLE ARM WITHIN SUBJECT CROSSOVER DESIGN PIVOTAL STUDY

  • STATUS
    Recruiting
  • participants needed
    10
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Updated on 19 February 2024

Summary

The POSEIDON study is a multi-center, prospective, single arm, crossover pivotal study enrolling up to 60 pivotal cohort patients and up to 30 additional Roll-in patients with refractory or recurrent ascites at up to 15 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.

Details
Condition Medical Research
Age 99years or below
Clinical Study Identifier03973866
Last Modified on19 February 2024

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