NCT02916953

CONFIRM - Study of AGN1 LOEP in Patients With Osteoporosis

Clinical Evaluation of the Safety of a Local Osteo-Enhancement Procedure (LOEP™) Intended to Increase Bone Strength in the Proximal Femur of Women in Europe With Osteoporosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: AgNovos Healthcare, LLC · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The study will evaluate the immediate procedure and post-procedure profile of the AGN1 Femoral LOEP™ Kit. All subjects will receive the treatment and be evaluated for any adverse or serious adverse events that could occur during the procedure or immediately post-procedure.

Detailed description

This research study will be conducted as a post-CE Mark prospective multi-center study within Europe. In total 60 patients will be treated with the OSSURE LOEP kit. Follow-up visits will be conducted ten (10) and forty-two (42) days after the procedure. In addition, all subjects will have the option to consent for a long term follow-up evaluation at twelve (12) months post-procedure.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DEVICE	AGN1 Femoral Local Osteo-Enhancement Procedure	A procedure that is intended to increase the strength of the proximal femur in individuals with osteoporosis of the femoral neck. Local treatment of the proximal femur with AGN1 is intended to be adjunctive to appropriate systemic therapy and overall osteoporosis management as directed by the patient's treating physicians.

Timeline

• Start date: 2016-12-17
• Primary completion: 2021-06-01
• Completion: 2022-04-01
• First posted: 2016-09-28
• Last updated: 2022-11-30

Locations

5 sites across 2 countries: Belgium, Netherlands

Regulatory

• FDA-regulated device study