NCT07631468招募中不适用
A Retrospective, Multi-center, Post-market Registry Study of Surgical Procedures in Endoscopy, Breast, and Urology (PROspect)
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 3
研究概览
简要总结
Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)
详细描述
The purpose of this study is to leverage standard of care data on clinical outcomes following surgical procedures as indicated for each device.
- Performance Objective: To collect clinical outcomes and Patient Reported Outcome Measures (PROMs) data (as applicable) on subjects that have undergone surgical breast procedures utilizing one or more Stryker devices.
- Safety Objective: To collect data on safety events on the use of Stryker devices and/or related procedures
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was ≥ 18 years of age at the time of the surgery
- •Patients who have undergone breast surgical procedures using MOLLI, SPY-PHI, and/or SPY AGENT GREEN
排除标准
- •Subjects who are less than 1-month post-intervention
- •Concurrent participation in an interventional investigational clinical study at the time of initial surgery
- •Subjects whose surgery date was prior to January
- •Pregnant or lactating females at the time of initial surgery
研究组 & 干预措施
Breast Surgical Procedures
Patients who have undergone breast surgical procedure (per product indications for use) using the Stryker device who meet all of the following criteria will be screened and enrolled by participating Investigators.
干预措施: Standard of care treatment (Device)
研究者
研究点 (3)
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