Post-Market, Non-Randomized, Multicentre PMCF Study to Monitor the Safety and Performance of Symani System in Microsurgical Reconstructive Procedures in a Real Life Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 427
- 试验地点
- 14
- 主要终点
- Procedure Robotic Success
研究概览
简要总结
Post Market Clinical Follow up Study aimed to collect clinical data on safety and efficacy of Robotically Assisted System called Symani to perform microsurgery techniques such as anastomosis, suturing and ligation for open surgery procedures on small anatomical structures such as blood vessels, lymphatic ducts and nerves.
详细描述
PMCF study aimed to monitor the safety, usability, performance and long-term efficacy of Symani. Furthermore, it will permit to detect potential emerging risks related to safety on the basis of clinical evidence through the observation of patients who have undergone microsurgical reconstructions using the Symani Surgical System in the usual setting of standard surgical practice.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged >18
- •Patients who need a reconstructive procedure and a microsurgical reconstruction is deemed the best option by the plastic, orthopedic or other surgeon in response to a post-oncological, post-traumatic or congenital tissue defect or to treat lymphedema.
- •Patients who have been selected by the PI at the Clinical Center as appropriate candidates for treatment with Symani System in accordance with the IFU.
- •Subjects who fit the criteria to perform surgery requiring reconstructions using free flaps, replantation, lymphatic reconstructions.
- •Subjects who agree to have the surgery and the anaesthesia.
- •Subjects who voluntarily decide to participate in this study with the surgery performed with the aid of the Symani System and sign the Informed Consent Form.
排除标准
- •Subjects who have bleeding or coagulation disorders in the past or present.
- •Any criteria that preclude prolonged anesthesia.
- •History of anaphylaxis or severe complicated allergy symptoms.
- •Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the data collection or the ability to comply with the protocol.
- •Evidence or history of autoimmune disease or compromised immune system.
- •Participation in another clinical trial within 4 weeks prior to participation in the study.
- •Subjects belonging to vulnerable populations or ineligible to participate for other reasons by the PI at a Clinical Center.
- •Subjects with pacemaker
研究组 & 干预措施
Robotic Assisted Microsurgery
Patients who meet the eligibility criteria for the study and undergo a microsurgical reconstruction using the Symani System according to its indications for use.
干预措施: Symani Surgical System (Device)
结局指标
主要结局
Procedure Robotic Success
时间窗: Procedure
Ability to complete the surgical task with Symani as intended by the surgeon
次要结局
- Complications(30 days)
- Free Flap/Replantation Failure(30 days)
- Limb volume reduction (for lymphatic surgery)(24 weeks)
- Anastomosis time(Procedure)
- Intraoperative redo(Procedure)
- Postoperative redo(7 days)
- Warm ischemia time(Procedure)