NCT06856707Enrolling By Invitation不适用
MIRA Surgical System Registry Study (MIRA Registry)
Virtual Incision Corporation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年4月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Performance of MIRA Surgical System
研究概览
简要总结
The purpose of the MIRA Surgical System Registry is to accumulate and evaluate real world evidence experience as part of post-market surveillance using the MIRA Surgical System.
The studies primary goals are to:
- To evaluate the performance of the MIRA Surgical System
- To evaluate the Device Safety profile
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing surgery using the MIRA Surgical System
- •Subject is able to provide informed consent
- •Subject is available for post operative follow up visit through 30 days
排除标准
- •Has or is participating in another clinical trial which may confound study results
- •In the opinion of the investigator, patient is not likely to complete post-operative care and/or return for standard follow-up.
结局指标
主要结局
Performance of MIRA Surgical System
时间窗: From time of procedure through completion of the surgical procedure
Successful completion of the surgical procedure using the MIRA Surgical System without conversion to open surgery (Yes/No).
Device Safety
时间窗: From time of surgery using the MIRA Surgical System through 30 days following surgical procedure
Incidence of Device related adverse events and Unanticipated Device Effects
次要结局
未报告次要终点
研究者
研究点 (1)
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