NCT07746531尚未招募不适用
ROBOTIC MINIMALLY INVASIVE HYSTERECTOMY POST-MARKET CLINICAL STUDY WITH THE DEXTER ROBOTIC SURGERY SYSTEM
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Primary safety outcome
研究概览
简要总结
The purpose of this post-market, observational study is to collect real-world data under anticipated conditions of use that demonstrates that the device performs as intended (accurate, precise control of surgical instruments) in patients undergoing robotic-assisted and laparoscopic hysterectomy for benign disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 22 years of age at time of enrollment/consent
- •Patient is planned to undergo robotic-assisted and laparoscopic hysterectomy for benign disease
- •Patient agrees to perform the 6-week follow-up assessment as per standard of care
排除标准
- •Any planned concomitant procedures (not including salpingectomy and/or oophorectomy)
- •Diagnosed malignant disease on reproductive organs
- •Uterus myomatous with fibroid > 10cm
结局指标
主要结局
Primary safety outcome
时间窗: up to 42 days after surgery
Occurrence of Clavien-Dindo grades III-V adverse events
Primary efficacy outcome
时间窗: Intraoperative
Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
次要结局
未报告次要终点
研究者
研究点 (2)
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