NCT06457971招募中不适用
Clinical Assessment Protocol: Anovo Surgical System in Ventral Hernia
Momentis Surgical2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2024年1月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Rate of Conversion
研究概览
简要总结
The study is aimed to clinically assess the AnovoTM Surgical System in ventral hernia procedures. Extensive preclinical testing of the system's integrity and safety has been performed to assure adequate safety for this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is at least 18 years old.
- •Subjects able to provide written informed consent.
- •Subject deemed eligible candidate by surgeon and will comply with the study procedures.
- •Subjects with ventral hernia.
- •Subjects with ASA grade I to III.
- •Subject must sign and date informed consent prior to treatment.
- •Subject can undergo general anesthesia per anesthesiologist assessment.
排除标准
- •Women who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical investigation.
- •Subject has medical condition, which in the judgement of the investigator makes the subject a poor candidate for the investigational procedure.
- •Participation in another clinical trial that is in the active phase.
- •Subject unwilling or inability to follow procedures outlined in the protocol.
- •Subjects who are not suitable for robotic surgery, the Subject will be excluded from the study and the will be considered a screen failure and the surgeon will proceed with a standard multiport laparoscopic Hernia repair.
- •Subjects who present any adverse event before use the Anovo Surgical System ("Anovo") that can affect evaluation of safety and performance of Investigational Device.
结局指标
主要结局
Rate of Conversion
时间窗: Intra-Operative
The primary endpoint is rate of conversion to open surgery or multiport laparoscopic approach. As this is a clinical assessment, no pre-determined success criteria have been set.
次要结局
- IntraOperative Procedural Outcomes - Time(Intra-Operative)
- Console Time(Intra-Operative)
- Docking Time(Intra-Operative)
- Draping Time(Intra-Operative)
- Post Operative Procedural Outcomes - AE and SADE(Through study completion, an average of 4 weeks.)
- Procedure Completion(Intra-Operative)
- IntraOperative Procedural Outcomes - AE and SADE(Intra-Operative)
- Post Operative Procedural Outcomes - SSI(Through study completion, an average of 4 weeks.)
- Post Operative Procedural Outcomes - Length of Stay(Through hospital discharge, up to approximately 3 days)
- IntraOperative Procedural Outcomes - Device/Procedure AE(Intra-Operative)
- Post Operative Procedural Outcomes - Wound Seroma(Through study completion, an average of 4 weeks.)
研究者
研究点 (2)
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终止
不适用
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