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Clinical Trial on the Effect of REGENETEN Bioinductive Implant in the Supraspinatus Tendon Repair

StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated September 19, 2024 (before its estimated February 28, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Minor Primary and study completion dates: Feb 2026 to Feb 28, 2026
    • Study title revised
    v6
  3. Notable Primary and study completion dates: Feb 2023 to Feb 2026v5
  4. Notable Primary and study completion dates: Jun 2022 to Feb 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 120 to confirmed 124
    • Site details revised
    v4
  5. Minor Re-verified, no change to tracked fieldsv3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2020 to Jun 17, 2020
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study aims a determine the effect that the addition of REGENETEN Bioinductive Implant has on Supraspinatus Tendon Repair. 120 patients will be included in this prospective, randomized, parallel group study.
Trial Details
NCT Number NCT04444076
Lead Sponsor Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Conditions
(from sponsor)
Supraspinatus Tear
Enrollment 124 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov