Clinical Trial

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

Active, Not Recruiting
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Summary
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.
Protocol Amendment History 26 amendments
This ClinicalTrials.gov record has been amended 26 times since 2021-04-05; most recent amendment 2026-05-06.
Status change: Recruiting → Active, Not Recruiting 2026-05-06
Status change: Not Yet Recruiting → Recruiting 2022-05-09
Trial Details
NCT Number NCT04835428
Lead Sponsor AgNovos Healthcare, LLC
Conditions Vertebral Compression Fracture, Compression Fracture, Vertebral Compression
Enrollment 408 participants
Start Date 2022-05-31
Primary Completion 2027-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-08