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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


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

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Subject was withdrawn from CONFIRM.
  2. 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.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details

Contition
Osteoporosis
Phase
NA
Participants needed
60
Est. Completion Date
Dec 31, 2025
Treatment type
INTERVENTIONAL
Sponsor
AgNovos Healthcare, LLC
ClinicalTrials.gov identifier
NCT04511364
Study number
AGN-CIP-300

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