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

Study acronym: POSEIDON
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 1, 2022 (before its estimated March 30, 2024 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment target: 111 to 110v14
  2. Enrollment target: 109 to 111
    • Study description revised
    v13
  3. Trial status: Recruiting to Active, Not Recruitingv12 Show 4 more changesShow less
    • Enrollment target: estimated 115 to confirmed 109
    • Study sites: 22 to 15
    • Primary completion date: Feb 28, 2024 to Mar 30, 2024
    • Study completion date: May 31, 2024 to Jun 30, 2024
  4. Primary completion date: Dec 31, 2021 to Feb 28, 2024v11 Show 5 more changesShow less
    • Enrollment target: 100 to 115
    • Study sites: 20 to 22
    • Study completion date: Mar 1, 2024 to May 31, 2024
    • Eligibility criteria expanded, about 62 words
    • Study description revised
  5. Study sites: 19 to 20v10 Show 4 more changesShow less
    • Primary completion date: Jul 31, 2021 to Dec 31, 2021
    • Study completion date: Oct 1, 2023 to Mar 1, 2024
    • Study description revised
    • Eligibility criteria shortened, about 2 words
Show 8 earlier versionsHide 8 earlier versions
  1. Trial status: Enrolling by Invitation to Recruiting
    • Site details revised at 19 of 19 sites
    v9
  2. Re-verified, no change to tracked fieldsv8
  3. Trial status: Recruiting to Enrolling by Invitation
    • Eligibility criteria expanded, about 30 words
    • Site details revised at 19 of 19 sites
    v7
  4. Enrollment target: 90 to 100v6
  5. Trial status: Enrolling by Invitation to Recruiting
    • Study sites: 20 to 19
    • Eligibility criteria expanded, about 26 words
    • Study description revised
    v5
  6. Study sites: 19 to 20
    • Primary completion date: May 31, 2021 to Jul 31, 2021
    v4
  7. Trial status: Not Yet Recruiting to Enrolling by Invitationv3 Show 4 more changesShow less
    • Study sites: 2 to 19
    • Primary completion date: Mar 31, 2021 to May 31, 2021
    • Study completion date: Jul 31, 2023 to Oct 1, 2023
    • Start date changed from estimate of Jul 1, 2019 to Sep 16, 2019
  8. Secondary endpoints revised (4)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03973866
Lead Sponsor Sequana Medical N.V.
Conditions
(from sponsor)		 Ascites
Related terms Ascites
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov