Klinische Interventionsstrategie Zur überbrückenden Behandlung Peripherer Nervendefekte Mit Neuromaix
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- proof of safety of the medical device Neuromaix
研究概览
简要总结
The aim of this study is the development and initial clinical application of the nerve guide Neuromaix in humans to provide evidence for the safety and performance of the device.
Neuromaix is intended to be used as a guiding structure to bridge a peripheral nerve discontinuity, and to create a conduit for axonal growth across the nerve gap.
详细描述
The Neuromaix nerve guide is an absorbable implant composed of porcine collagen, used to bridge a peripheral nerve discontinuity, and to create a conduit for axonal growth across the nerve gap. Neuromaix provides a protective environment for peripheral nerve regeneration after injury. Neuromaix connects the proximal and distal ends of a transected nerve, allowing regenerating axons to grow through the scaffold, into the distal nerve tissue towards the target muscle or skin.
Neuromaix is composed of two parts. The Epimaix part provides the structural characteristics needed to suture the nerve guide in place and to prevent ingrowth of scar tissue. The Perimaix part provides a structure that mimics endoneurial tubes, providing guidance for the regenerating axons while bridging the nerve gap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both genders in the age between 18 und 70 years
- •patients who are scheduled for a nerve biopsy
排除标准
- •alcohol-related polyneuropathy
- •paraneoplastic polyneuropathy
- •present: immunosuppressive therapy
- •present: malignant tumor
- •peripheral vascular diseases
- •collagen diseases (e.g. existing keloid scars)
- •patients with an increased wound healing disorder (e.g. diabetics)
- •patients with chronic venous insufficiency (vein thrombosis, skin diseases)
- •patients with coagulation and bleeding disorders (ASA- or Marcumar-patients)
- •present: pregnancy
- •HIV, Hepatitis B or Hepatitis C infection
结局指标
主要结局
proof of safety of the medical device Neuromaix
时间窗: 12 months
The primary objective is the proof of safety of the medical device Neuromaix. key parameter: normal wound healing without complications
次要结局
- effectiveness evaluation of the implant device Neuromaix(12 months)
