This record was last updated January 31, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP.
To qualify, subjects must have previously consented, enrolled, and been treated with the AGN1 LOEP kit in CONFIRM (AgNovos Study PST-EU-101.1).
Follow-up evaluations will be conducted at 24, 36, 48 and 60 months from the date the subject originally received the AGN1 LOEP treatment. Subjects will receive DXA and X-ray imaging at the 24- and 60-month follow-up visits. The 36- and 48-month follow-up evaluations will be conducted by phone. All timepoints will include general health and medical record review.
Protocol Amendment History
7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2020-08-12; most recent amendment 2025-01-29.
Status change: Recruiting → Active, Not Recruiting2025-01-23
Status change: Not Yet Recruiting → Recruiting2020-08-28