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RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 4 to 3
    v11
  2. Study description expanded, about 76 words
    • Site details revised at 4 of 4 sites
    • Eligibility criteria shortened, about 5 words
    v10
  3. Primary completion date: Dec 1, 2024 to Dec 1, 2027
    • Study completion date: Dec 1, 2026 to Dec 1, 2028
    • Site details revised at 4 of 4 sites
    v9
  4. Site details revised at 1 of 4 sitesv8
  5. Primary completion date: Nov 1, 2023 to Dec 1, 2024
    • Study completion date: Nov 1, 2024 to Dec 1, 2026
    • Site contacts updated at 1 of 4 sites
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 1 of 4 sitesv6
  2. Study title expanded, about 2 wordsv5
  3. Study sites: 3 to 4v4
  4. Study sites: 1 to 3v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2021 to May 19, 2021
    • Site details revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is a prospective, single-arm, multi-center, European clinical study designed to evaluate the clinical performance and safety of the AGN1 LOEP SV Kit for the treatment of painful VCFs.
Trial Details
NCT Number NCT04821739
Lead Sponsor AgNovos Healthcare, LLC
Conditions
(from sponsor)		 Vertebral Compression Fracture, Vertebral Compression, Vertebral Fracture
Related terms Spinal Fractures
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov