A Prospective, Multicenter, Single-arm Clinical Trial Evaluating Safety and Performance of TISSIUMTM Nerve Coaptation Device for the Repair of Digital Nerve Discontinuities Where Gap Closure Can be Achieved by Flexion of the Extremity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Tissium
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Cumulative incidence of complications (CIC) related to the investigational device
研究概览
简要总结
The purpose of this study is to collect initial safety and device performance data of the TISSIUM's nerve coaptation device for the sutureless repair of digital nerve injuries of the hand in which there has been no substantial loss of nerve tissue. Additional clinical measures that assess device performance, use, and patient reported outcomes will be collected to guide future study design and potential device modifications.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing a repair of a proper digital nerve of the hand;
- •100% transection injury to the nerve under repair;
- •Gap closure between the nerve ends can be achieved by flexion of the extremity without excessive tension;
- •Clean surgical wound with sufficient healthy soft tissue that enables primary closure without adjunctive soft tissue procedures;
- •Patient willing and able to provide a signed Patient Informed Consent Form;
- •Patient willing and able to follow the study instructions and likely to complete all required study procedures and visits.
排除标准
- •Patient has a known allergy to the constituent polymer of the investigational device;
- •Patient has a documented diagnosis of peripheral neuropathy;
- •Patient has a history of neuropathic pain;
- •Patient has a history of injury to the nerve being studied;
- •Patient has is missing the contralateral digit or with a history of injury to the contralateral digit (comparison control area);
- •Patient is pregnant or nursing
- •Any patient with a diagnosis of type 1 Diabetes Mellitus;
结局指标
主要结局
Cumulative incidence of complications (CIC) related to the investigational device
时间窗: through 12-months post-procedure
CIC includes the occurrence of any of the following complications: * Infection * Chronic pain (defined as pain lasting more than 3 months) not otherwise specified * Excessive inflammation as determined by the investigator * Device extrusion * Symptomatic neuroma formation * Impaired wound healing (examples are dehiscence, pain, skin irritation, keloid, scar hypertrophy) * Allergic reaction to the constituent polymer of the investigational device * Serious Adverse Device Effect (SADEs)
次要结局
- Semmes-Weinstein monofilament (SWMF) for nerve functional recovery(at 6 months post-procedure)