The GentleWave Post-Market Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Healing
研究概览
简要总结
The purpose of this registry is to gain a real world perspective for the use and outcomes associated with the Sonendo® GentleWave System usage. The registry population includes up to 500 subjects that have been treated with the Sonendo GentleWave System at up to 25 clinical sites in the United States.
详细描述
The purpose of this registry is to gain a real world perspective for the use and outcomes associated with the Sonendo® GentleWave System usage.
Up to 25 clinical sites in the United States. Up to 500 subjects that have been treated with the Sonendo GentleWave System. To assess outcomes for teeth treated with the GentleWave System in a commercial setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One or more teeth treated with the Sonendo GentleWave System
排除标准
- •Institutionalized patients or prisoners
结局指标
主要结局
Healing
时间窗: 24 months
Radiographic analysis and clinical signs and symptoms at 24 months
次要结局
- Retreatment Rates(24 months)
