NCT05229094已完成不适用
EVA Nexus Field Observation Study. A Monocentric, Academic Field Observation Study of a Prototype of a New CE-labeled Vitrectomy Device Developed by DORC BV (The Netherlands).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- to evaluate the intra-operative safety of a new surgical device
研究概览
简要总结
determine the safety and effectiveness of the device.
详细描述
To perform a field observation study using the newly developed EVA Nexus vitrectomy device.
Patients that are scheduled for intra-ocular surgery regardless of the indication:
- Vitrectomy surgery
- Cataract surgery
- Vitrectomy combined with cataract surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that are scheduled for intra-ocular surgery regardless of the indication:
- •Vitrectomy surgery
- •Cataract surgery
- •Vitrectomy combined with cataract surgery
- •In case of (combined) vitrectomy: primary or repeat vitrectomy
- •General or retrobulbar anesthesia, the latter can be combined with sedation
- •Patients aged ≥ 18 years
排除标准
- •Patients aged < 18 years
结局指标
主要结局
to evaluate the intra-operative safety of a new surgical device
时间窗: 2 days
specific adverse events that may occur during the (phaco) vitrectomy will be recorded to assess the surgical safety.
次要结局
- To evaluate possible (S)AE that may be related to the use of the surgical platform.(2 days)
- To evaluate the possible reduction of total surgical time(1 day)
- To evaluate the impact of usage of the EVA NEXUS on the surgical parameters used during the procedure(2 days)
研究者
研究点 (1)
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