MedTrace Logo

GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)

NCT07594639 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 305

Last updated 2026-05-19

No results posted yet for this study

Summary

The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated between September 2019 and January 2026. Subjects treated as part of an AgNovos prior protocoled study are excluded. Investigators are asked to reach out to all subjects that were previously treated with the AGN1 LOEP Kit in the proximal femur. Subject informed consent is obtained before a subject is enrolled into the study. Subjects treated but not enrolled are documented in a log with the reason why a subject did not participate. This log is kept on site. Enrolled subjects will be contacted per telephone to collect information about any fractures sustained post-AGN1 LOEP treatment.

Conditions

Interventions

DEVICE

AGN1 LOEP

Patients treated with AGN1 LOEP

Sponsors & Collaborators

  • AgNovos Healthcare, LLC

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-09-30
Completion
2026-09-30

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 NCT07594639 on ClinicalTrials.gov