GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients
- Conditions
- Osteoporosis
- Registration Number
- NCT05966974
- Lead Sponsor
- AgNovos Healthcare, LLC
- Brief Summary
The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated outside of any other clinical study protocols between September 2019 and November 2022. A prospective questionnaire will be included to evaluate self-reported subject experiences.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Subject has previously received AGN1 LOEP treatment between September 2019 and November 2022.
- Subject has willingness to participate in the study.
- Subject can give written informed consent to allow for data collection.
- The subject's AGN1 LOEP treatment was previously performed as part of a prior protocoled clinical study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subject Safety Through study completion, an average of 1.1 years Incidence of all adverse events and serious adverse events occurring post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device.
Subject satisfaction Through study completion, an average of 1.1 years Satisfaction level of subjects as measured by a Visual Analog Scale. The scale ranges from the lowest possible satisfaction to the highest possible satisfaction.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vitaz
🇧🇪Sint-Niklaas, Belgium