NCT05199155终止2 期
Phase II Study Evaluating the Safety and Efficacy of NerVFIX Treatment for Trauma or Accidental Nerve Section of the Wrist
TBF Genie Tissulaire2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年12月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Recovery of sensory function
研究概览
简要总结
The purpose of this open, multicenter trial is to assess the impact of a nerve regeneration conduit made of allogeneic artery or vein from umbilical cord lining on the regeneration of wrist nerve.
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
- •Men and women over 18 years of age and under 65 years of age
- •One wrist nerve section ( medial, ulnar) with a minimum of 2 mm and maximum gap of 2 cm evaluated during the surgical procedure (Sunderland Grade V)
- •Inclusion of direct suture with wrapping or nerve defect with NerVFIX for nerve junction
- •Poor outcome on the Mackinnon-Dellon scale: < S3
- •Within 1 month of the injury or accident event and/or at the time of the injury (emergency procedure)
- •Any damaged artery must be repaired
- •Patient with no poor vascularization risk (no surgical treatment of vessel section) or no disease linked to poor vascularization.
- •Patient who received the study information and provided consent
- •Patients who are members or the beneficiary of a national health insurance plan
排除标准
- •Breast feeding women or women without effective contraception (if no effective contraception: a pregnancy test is mandatory)
- •Digital nerve section
- •Pregnant or breast feeding women: Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method
- •Patient who suffered amputation of the hand in question
- •Surgical site infection or necrotic area; tendon and/or bone damage
- •Underlying motor or sensory disorder that could compromise the evaluation; inflammatory arthritis causing pain
- •Disease that compromises healing such as diabetes, alcoholism or skin disorder
- •Vascular disease leading to reduced blood flow or altered microvascularisation such as Raynaud's disease
- •Subjects who are unlikely to follow through with rehabilitation or who could be addicted to drugs or alcohol; heavy smokers will be asked to stop smoking voluntarily
- •Persons confined by a judicial or administrative decision
- •Adults subject to legal protection measures or who are unable to provide their consent
研究组 & 干预措施
NerVFIX
Experimental
Biological regeneration nerve conduit of allogeneic artery or vein from umbilical cord used as a conduit for gap < 2 cm or as a wrap after peripheral nerve suture
干预措施: NerVFIX (Biological)
结局指标
主要结局
Recovery of sensory function
时间窗: 12 months
Recovery of sensitivity in the nerve section area evaluated using the static 2-Point Discrimination (s2PD)
次要结局
- Progressive recovery of sensory function(15 days, 1 month, 3 months, 6 months, 12 months)
- Decrease of the score of symptoms related to nerve section(15 days, 1 month, 3 months, 6 months, 12 months)
- Improvement of the touch-pressure threshold of the hand(15 days, 1 month, 3 months, 6 months, 12 months)
- Percentage of nerve regeneration(1 month, 3 months, 6 months, 12 months)
- Improvement of health-related quality of life(15 days, 1 month, 3 months, 6 months, 12 months)
- Improvement of clinical motricity(15 days, 1 month, 3 months, 6 months, 12 months)
研究者
研究点 (2)
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