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临床试验/NCT01884376
NCT01884376已完成不适用

Klinische Interventionsstrategie Zur überbrückenden Behandlung Peripherer Nervendefekte Mit Neuromaix

RWTH Aachen University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年7月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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