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RECRUITING
NCT05202678
NA

RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis

Sponsor: AgNovos Healthcare, LLC

View on ClinicalTrials.gov

Summary

The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label 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 in European countries where AGN1 LOEP is commercially available. AGN1 is intended to form new bone in voids in the proximal femur of women with osteoporosis.

Official 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

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2021-07-05

Completion Date

2026-12

Last Updated

2025-01-31

Healthy Volunteers

No

Conditions

Interventions

DEVICE

AGN1 LOEP

Subjects with osteoporosis are treated with AGN1 local osteo-enhancement procedure in the proximal femur

Locations (1)

AZ Nikolaas

Sint-Niklaas, Antwerpen, Belgium