MedTrace Logo

RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis

NCT05202678 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-01-31

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

AGN1 LOEP

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

Sponsors & Collaborators

  • AgNovos Healthcare, LLC

    lead INDUSTRY

Principal Investigators

  • Jo De Schepper, MD · AZ Nikolaas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05202678 on ClinicalTrials.gov