Study of Elective AGN1 LOEP in Osteopenic and Osteoporotic Subjects - a Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Subject Safety
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has previously received AGN1 LOEP treatment between September 2019 and November
- •Subject has willingness to participate in the study.
- •Subject can give written informed consent to allow for data collection.
排除标准
- •The subject's AGN1 LOEP treatment was previously performed as part of a prior protocoled clinical study.
结局指标
主要结局
Subject Safety
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点