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CONFIRM EXTENSION - Long-term Follow-up Study of Patients Treated with AGN1 LOEP | Clinical Trials | Clareo Health

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

Long-term Follow-up in Osteoporotic Women Treated with Local Osteo-Enhancement in Europe

NCT04511364•AgNovos Healthcare, LLC

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.

Eligibility

Age

All ages

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Subject had previously enrolled in CONFIRM and received AGN1 LOEP treatment.
•Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
•Subject is capable of giving written informed consent to participate in the study.

Exclusion Criteria

•Subject was withdrawn from CONFIRM.
•Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate.

Locations (1)

AZ Nikolaas

Sint-Niklaas, Sint-Niklaas, Belgium

Key Dates

Start Date

August 28, 2020

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

January 31, 2025

Enrollment

ESTIMATED participants

Conditions

Osteoporosis

Interventions

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

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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