NCT07427823尚未招募不适用
Clinical Safety and Performance Evaluation of MUSA-3 in Microsurgical Anastomoses
Microsure0 个研究点目标入组 30 人开始时间: 2026年4月20日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Safety: device-related adverse events (AEs)
研究概览
简要总结
This study is conducted to evaluate the safety and performance of robot-assisted microsurgical anastomoses with the MUSA-3 system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Patient age ≥ 18 years.
- •Patients requiring procedures involving micro-anastomosis of small anatomical structures-such as blood vessels, nerves, or lymphatic vessels-in free flap, lymphatic, or peripheral nerve surgery.
- •Patients who have been selected by the research team at the Clinical Center as appropriate candidates for treatment with MUSA-3 in accordance with the IFU.
- •Able to give informed consent before participating in the study.
- •Provision of signed and dated informed consent form.
排除标准
- •Subject participates in a potentially confounding drug or device trial during the course of the study.
- •Patients that are pregnant or breastfeeding.
- •For Lymphedema patients:
- •≥ISL (International Society of Lymphology) Stage III lymphedema
- •History of marcaine or indocyanine green allergy
- •Non-viable lymphatic system as determined by ICG lymphatic mapping using near infrared camera
研究组 & 干预措施
Robot-assisted anastomoses
Experimental
干预措施: Robot-assisted microsurgical anastomoses (Device)
结局指标
主要结局
Safety: device-related adverse events (AEs)
时间窗: Intraoperatively and through the 30-day post-procedure period
Performance: conversion rate to manual procedure
时间窗: Intraoperatively
Clinical performance: vessel patency rate
时间窗: Intraoperatively
次要结局
- Anastomosis quality (SAMS score)(Intraoperatively)
- Anastomosis time(Intraoperatively)
研究者
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