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CONFIRM EXTENSION - Long-term Follow-up Study of Patients Treated with AGN1 LOEP

NCT04511364 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-31

No results posted yet for this study

Summary

The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP.

To qualify, subjects must have previously consented, enrolled, and been treated with the AGN1 LOEP kit in CONFIRM (AgNovos Study PST-EU-101.1).

Follow-up evaluations will be conducted at 24, 36, 48 and 60 months from the date the subject originally received the AGN1 LOEP treatment. Subjects will receive DXA and X-ray imaging at the 24- and 60-month follow-up visits. The 36- and 48-month follow-up evaluations will be conducted by phone. All timepoints will include general health and medical record review.

Conditions

Interventions

OTHER

Clinical imaging is performed during the 24 and 60 month follow-up visits

X-ray and DXA scan

Sponsors & Collaborators

  • AgNovos Healthcare, LLC

    lead INDUSTRY

Principal Investigators

  • Jo De Schepper, MD · AZ Nikolaas

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-28
Primary Completion
2025-12-31
Completion
2025-12-31

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 NCT04511364 on ClinicalTrials.gov