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CONFIRM EXTENSION - Long-term Follow-up Study of Patients Treated with AGN1 LOEP

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 31, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Re-verified, no change to tracked fieldsv8
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    • Study title expanded, about 1 word
    v7
  3. Study title expanded, about 5 wordsv6
  4. Site contact updatedv5
  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2020 to Aug 28, 2020
    • Site details revised
    v3
  2. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT04511364
Lead Sponsor AgNovos Healthcare, LLC
Conditions
(from sponsor)		 Osteoporosis
Related terms Hip Fractures, Osteoporosis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov