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STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Dec 31, 2025 to Dec 31, 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 19 to 12
    • Study completion date: Dec 31, 2027 to Dec 31, 2029
    v27
  2. Re-verified, no change to tracked fieldsv26
  3. Site details revised at 2 of 19 sitesv25
  4. Site details revised at 15 of 19 sitesv24
  5. Re-verified, no change to tracked fieldsv23
Show 21 earlier versionsHide 21 earlier versions
  1. Site details revised at 2 of 19 sitesv22
  2. Site details revised at 1 of 19 sitesv21
  3. Study sites: 18 to 19v20
  4. Site details revised at 17 of 18 sitesv19
  5. Study sites: 17 to 18v18
  6. Site details revised at 1 of 17 sitesv17
  7. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    • Site details revised at 1 of 17 sites
    v16
  8. Study sites: 18 to 17v15
  9. Site details revised at 2 of 18 sitesv14
  10. Study sites: 14 to 18
    • Study description expanded, about 91 words
    v13
  11. Study sites: 15 to 14
    • Eligibility criteria expanded, about 26 words
    v12
  12. Study completion date: Dec 31, 2024 to Dec 31, 2026
    • Site details revised at 2 of 15 sites
    v11
  13. Site contacts updated at 1 of 15 sitesv10
  14. Site details revised at 3 of 15 sitesv9
  15. Study title expanded, about 2 wordsv8
  16. Eligibility criteria shortened, about 7 words
    • Site details revised at 2 of 15 sites
    v7
  17. Study sites: 9 to 15v6
  18. Study sites: 6 to 9
    • Start date changed from estimate of May 27, 2022 to May 31, 2022
    v5
  19. Trial status: Not Yet Recruiting to Recruitingv4 Show 5 more changesShow less
    • Enrollment target: 246 to 408
    • Primary and study completion dates: Jun 30, 2024 to Dec 31, 2024
    • Start date: Sep 30, 2021 to May 27, 2022
    • Study sites: 0 to 6
    • Eligibility criteria expanded, about 23 words
  20. Primary endpoints: 4 to 5v3
  21. Primary completion date: Jun 30, 2023 to Jun 30, 2024
    • Primary endpoints: 3 to 4
    • Eligibility criteria expanded, about 6 words
    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 is a multicenter, single-blinded, randomized controlled clinical trial evaluating the safety and efficacy of the AGN1 LOEP SV Kit for the treatment of painful vertebral compression fragility fractures (VCFs). The objective of this study is to demonstrate non-inferiority of the AGN1 LOEP SV Kit for the treatment of VCFs to standard of care vertebroplasty treatment using bipedicular injection of PMMA bone cement.
Trial Details
NCT Number NCT04835428
Lead Sponsor AgNovos Healthcare, LLC
Conditions
(from sponsor)		 Vertebral Compression Fracture, Compression Fracture, Vertebral Compression
Related terms Fractures, Compression
Enrollment 408 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov