Clinical Trial

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

Active, Not Recruiting
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Summary
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2021-03-25; most recent amendment 2026-05-11.
Status change: Recruiting → Active, Not Recruiting 2026-05-11
Status change: Not Yet Recruiting → Recruiting 2021-07-19
Trial Details
NCT Number NCT04821739
Lead Sponsor AgNovos Healthcare, LLC
Conditions Vertebral Compression Fracture, Vertebral Compression, Vertebral Fracture
Enrollment 100 participants
Start Date 2021-05-19
Primary Completion 2027-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-13