ACTRN12616001157460已完成未知
Case Series Study: Surgical Repair of Peripheral Nerve Injury with CelGro Registered TrademarkCollagen Scaffold.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •Male or female aged 18-50 years.
- •Traumatic injury to one or more peripheral nerves of the upper limb or hand requiring surgical repair.
- •Nerve gap <20mm.
- •Able to require to the requirements of the protocol.
- •Able to give informed consent or has legally acceptable representative who can give informed consent in accordance with ICH/GCP.
排除标准
- •Nerve gap >20mm
- •Active infection or systemic pathology including inflammatory joint disease, HIV, uncontrolled or poorly controlled diabetes, hepatitis or neoplastic disorders.
- •Known hypersensitivity to the study treatment or its excipients or known relevant medication allergy.
- •Female participant who is pregnant or lactating.
- •Known substance abuse.
- •Participation in another study with an investigational product within the last 3 months of study treatment date.
- •Concurrent medical condition which precludes the administration of the study treatment.
- •Other clinically significant disease (including psychological disorders) or medical condition that would, in the opinion of the Investigator, compromise the safety of the participant or the outcome of the study.
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