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PMCF Study of LiquiBand FIX8® OHMF Device

Study acronym: LBF8-Open
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Trial status: Recruiting to Active, Not Recruitingv15 Show 4 more changesShow less
    • Enrollment target: estimated 107 to confirmed 109
    • Primary completion date changed from estimate of May 2025 to Jul 31, 2025
    • Study completion date: Aug 2025 to Jul 31, 2026
    • Site details revised at 3 of 3 sites
  2. Minor Re-verified, no change to tracked fieldsv14
  3. Notable Primary completion date: Feb 2023 to May 2025
    • Study sites: 1 to 3
    • Study completion date: Feb 2024 to Aug 2025
    v13
  4. Notable Trial status: Not Yet Recruiting to Recruitingv12 Show 4 more changesShow less
    • Primary completion date: May 2022 to Feb 2023
    • Study sites: 0 to 1
    • Study completion date: May 2023 to Feb 2024
    • Start date changed from estimate of Nov 2021 to Dec 7, 2021
  5. Notable Start date: Sep 2021 to Nov 2021
    • Primary completion date: Mar 2022 to May 2022
    • Study completion date: Mar 2023 to May 2023
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Notable Start date: Jul 2021 to Sep 2021
    • Primary completion date: Jan 2022 to Mar 2022
    • Study completion date: Jan 2023 to Mar 2023
    v10
  2. Notable Start date: May 2021 to Jul 2021
    • Primary completion date: Nov 2021 to Jan 2022
    • Study completion date: Nov 2022 to Jan 2023
    v9
  3. Notable Start date: Mar 2021 to May 2021
    • Primary completion date: Sep 2021 to Nov 2021
    • Study completion date: Sep 2022 to Nov 2022
    • Study description shortened, about 70 words
    v8
  4. Minor Secondary endpoints revised (7)v7
  5. Notable Start date: Oct 2020 to Mar 2021
    • Primary completion date: Mar 2021 to Sep 2021
    • Study completion date: Mar 2022 to Sep 2022
    v6
  6. Notable Start date: Aug 2020 to Oct 2020
    • Primary completion date: Feb 2021 to Mar 2021
    • Study completion date: Feb 2022 to Mar 2022
    v5
  7. Notable Start date: Jun 2020 to Aug 2020
    • Primary completion date: Jul 2021 to Feb 2021
    v4
  8. Notable Primary completion date: Apr 2020 to Jul 2021
    • Start date: Oct 2019 to Jun 2020
    • Study completion date: Apr 2021 to Feb 2022
    • Secondary endpoints: details revised at 3 of 7 entries
    v3
  9. Minor Secondary endpoints: details revised at 1 of 7 entriesv2
  1. Minor 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.
Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
Trial Details
NCT Number NCT04059640
Lead Sponsor Advanced Medical Solutions Ltd.
Collaborators: Imarc Research, Inc.
Conditions
(from sponsor)
Inguinal Hernia
Related terms Hernia, Inguinal
Enrollment 109 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov