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Irrisept Spinal Fusion Pilot Study Protocol

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 19, 2024 (before its estimated December 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Enrolling by Invitation
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation Primary completion date: Dec 2023 to Dec 2024 · Start date changed from estimate of Sep 2021 to Jun 6, 2022 · Completion date: May 2024 to Dec 2024 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Dec 2023 to Dec 2024
    • Start date changed from estimate of Sep 2021 to Jun 6, 2022
    • Completion date: May 2024 to Dec 2024
    • Site contact updated
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objectives include assessing the use of Irrisept irrigation solution in lumbar spinal fusion procedures and effect on clinical and patient reported outcome measures. This includes assessing postoperative SSI as well as fusion rates in addition to patient reported outcome measures.
Trial Details
NCT Number NCT05011942
Lead Sponsor University of Kansas Medical Center
Collaborators: Irrimax Corporation
Conditions Lumbar Spine Disease
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov