RECONFIRM - AGN-CIP-301 version 4
Research type
Research Study
Full title
Prospective, Post-market Evaluation of Safety and Efficacy of a Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur of Women in Europe with Osteoporosis
IRAS ID
318519
Contact name
Benjamin John Ollivere
Contact email
Sponsor organisation
AgNovos Healthcare USA, LLC
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
Fragility fractures of the hip (i.e., a fracture due to a low-energy trauma such as a fall from headroom) are associated with significant morbidity and mortality and pose a significant burden to affected individuals, families and health care systems. Osteoporosis - a disease characterized by reduced bone mass – is a key factor contributing to the risk of hip fractures. Despite the availability of current treatment options for osteoporosis, there are still remaining gaps, suggesting the need for new therapies.
The primary goal of the study is to evaluate the post-market safety and Bone Mineral Density (BMD) improvement of AGN1 LOEP in patients with osteoporosis in at least one hip. The secondary objective is to evaluate the post-market functional measurements of clinical performance and patient satisfaction of the AGN1 LOEP.
The research will be conducted as a prospective, post-market evaluation of safety and efficacy of the Local Osteo-Enhancement Procedure (LOEP) in the proximal femur of women in Europe. It will be a multi-center study. The study will collect procedural, short- and long-term data on the safety and clinical performance of AGN1 LOEP in the post-market setting. It is expected that the duration of the entire study, including a recruitment phase, treatment, and follow-up, will be approximately 4 years. The participation of each patient in the study will take 2 years.REC name
HSC REC A
REC reference
23/NI/0092
Date of REC Opinion
30 Aug 2023
REC opinion
Further Information Favourable Opinion