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CONFIRM EXTENSION - Long-term Follow-up Study of Patients Treated with AGN1 LOEP
Sponsor: AgNovos Healthcare, LLC
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.
Official title: Long-term Follow-up in Osteoporotic Women Treated with Local Osteo-Enhancement in Europe
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2020-08-28
Completion Date
2025-12
Last Updated
2025-01-31
Healthy Volunteers
No
Conditions
Interventions
Clinical imaging is performed during the 24 and 60 month follow-up visits
X-ray and DXA scan
Locations (1)
AZ Nikolaas
Sint-Niklaas, Sint-Niklaas, Belgium