Status:
ACTIVE_NOT_RECRUITING
CONFIRM EXTENSION - Long-term Follow-up Study of Patients Treated with AGN1 LOEP
Lead Sponsor:
AgNovos Healthcare, LLC
Conditions:
Osteoporosis
Eligibility:
FEMALE
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- Subject was withdrawn from CONFIRM.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.
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04511364
Start Date
August 28 2020
End Date
December 1 2025
Last Update
January 31 2025
Active Locations (1)
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1
AZ Nikolaas
Sint-Niklaas, Sint-Niklaas, Belgium, 9100