CONFIRM Europe Safety Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
Summary
- Conditions
- Osteoporosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Only males
Description
This research study will be conducted as a post-CE Mark prospective multi-center study within Europe. In total 60 patients will be treated with the OSSURE LOEP kit. Follow-up visits will be conducted ten (10) and forty-two (42) days after the procedure. In addition, all subjects will have the option...
This research study will be conducted as a post-CE Mark prospective multi-center study within Europe. In total 60 patients will be treated with the OSSURE LOEP kit. Follow-up visits will be conducted ten (10) and forty-two (42) days after the procedure. In addition, all subjects will have the option to consent for a long term follow-up evaluation at twelve (12) months post-procedure.
Tracking Information
- NCT #
- NCT02916953
- Collaborators
- KCR S.A.
- genae Group
- Investigators
- Principal Investigator: Jo De Schepper, MD AZ Nikolaas
Get Well Soon