An Open-Label Study Using NTX-001 to Repair Peripheral Nerve Transection(s)
试验速览
- 阶段
- 不适用
- 状态
- Available
- 发起方
- 试验地点
- 3
研究概览
简要总结
The proposed use of NTX-001 for transections of upper extremity and facial peripheral nerves, acutely or planned.
详细描述
For this expanded access program, there is a case-by-case internal review process conducted by Neuraptive after the respective investigator provides a prospective case narrative for enrollment consideration.
Allowed Sunderland Classifications are IV degree (Seddon's Class II) and V degree (Seddon's Class III). If the case is approved, the investigator can move forward.
Patients who are between twelve (12) and eighty (80) years of age and has clinical evidence of a peripheral nerve transection from conditions or interventions that has or may result in motor and/or sensory impairment and require surgical treatment. All peripheral nerve repairs including gap repairs (autografts) will be considered for enrollment.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. The patient has clinical evidence of a peripheral nerve transection from conditions or interventions that has or may result in motor and/or sensory impairment and requires surgical treatment.
排除标准
- •Patients whose nerve repair will occur greater than 48 hours after nerve transection.
- •Patients requiring repair of the intracranial portion of any nerve.
- •Patients requiring a nerve repair involving an allograft or conduit.
- •Patients expected to show signs of spontaneous recovery by 12 months (e.g., Bell's palsy).
- •Patients who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow-up due to significant muscle atrophy or other morbidity.
- •The patient has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease, systemic neurological deficit, or other treatments known to affect the growth and/or physiology of the neural and vascular system).
- •The patient has a known allergy to polyethylene glycol (PEG) or human grade silicone.