NCT04865679进行中（未招募）不适用
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Safety: Adverse Events (AEs), Serious Adverse Events (SAEs), or Unanticipated Adverse Device Effects (UADEs)
研究概览
简要总结
This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention to the nerve injuries is not possible.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Potential Subjects MUST:
- •Sign and date an IRB-approved written Informed Consent Form prior to initiation of any study procedures;
- •Be an adult male or female ≥ 18 and ≤ 80 years of age;
- •Present for surgery with either:
- •Limb trauma and/or planned amputation of a limb and be candidates who are planned for a secondary nerve surgery such as Targeted Muscle Reinnervation (TMR) or Regenerative Peripheral Nerve Interface (RPNI) procedures within 6-12 months from time of amputation, or;
- •A previous amputation and be undergoing surgery to address nerve ends;
- •Have at least one nerve end measuring greater than 4 mm and less than 7 mm in diameter after debridement and hemostasis of the proximal nerve stump;
- •Have sufficient soft tissue available to be adequately covered by the Axoguard Nerve Cap;
- •Be willing and able to comply with all aspects of the treatment and follow-up assessments and to return for all required study visits throughout the study duration.
排除标准
- •Potential Subjects MUST NOT:
- •Currently undergoing or are expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment that affects the growth of neural and/or vascular tissues;
- •Have signs and symptoms of chemotherapy-induced peripheral neuropathy from previous chemotherapy;
- •Be immunosuppressed or have planned immunosuppressive therapy during the duration of the study;
- •Current uncontrolled local or systemic infection as indicated by positive blood culture or other pathological indicators of infection;
- •Be contraindicated for soft tissue implants. This includes but is not limited to any pathology that would limit the blood supply to the target area or otherwise compromise healing;
- •Have a life expectancy of less than 15-months;
- •Have a history of or be planning to undergo radiotherapy in the area of the end-neuroma;
- •Have bony exostosis of the affected limb that is not treated at the time of nerve cap placement;
- •Have uncontrolled Type 1 or Type 2 Diabetes Mellitus with HbA1c of 8% or greater or those with diabetic neuropathy in the target area or proximal to the amputation site;
- •Have a history of idiopathic neuropathy/radiculopathy, known sciatica or chronic back pain;
- •Documented history of centralized nerve pain that does not respond to a peripheral nerve block in the affected limb;
- •Have a known allergy to anesthetic agents;
- •Have a known sensitivity to porcine-derived products;
- •Be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or
- •Be deemed unsuitable for inclusion in the study at the discretion of the investigator.
研究组 & 干预措施
Axoguard Nerve Cap®
Experimental
Active Comparator: Porcine derived extracellular matrix (ECM) based Nerve Termination Device
Implantation of appropriate diameter of Axoguard Nerve Cap® (sizes 5-7 mm) at the time of surgery
干预措施: Axoguard Nerve Cap® (Device)
结局指标
主要结局
Safety: Adverse Events (AEs), Serious Adverse Events (SAEs), or Unanticipated Adverse Device Effects (UADEs)
时间窗: 15 Months
The primary safety endpoint will monitor the nature and incidence of AE's, SAE's and/or UADE's associated with an unplanned revision procedure prior to the planned Targeted Muscle Reinnervation (TMR) or Regenerative Peripheral Nerve Interface (RPNI) starting from implantation (operative day) through 15 months depending on whether or not the subject undergoes the secondary TMR or RPNI procedure.
次要结局
- Change in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) through TMR or RPNI procedure or 12 post-operative months compared to baseline(Week 2, 1, 3, 6, 9 and 12 months)
- Change in Brief Activities Measure for Adults with Upper Limb Amputation (BAM-ULA) through 12 post-operative months compared to baseline(3, 6, 9 and 12 months)
- Change in Visual Analog Scale (VAS) For Pain Score through TMR procedure or 12 post-operative months compared to baseline(Week 2, 1, 3, 6, 9 and 12 months)
- Change in Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures through TMR or RPNI procedure or 12 post operative months compared to baseline(Week 2, 1, 3, 6, 9 and 12 months)
- Change in the 10-Meter Walk Test (10 MWT) for Lower Extremity Amputees through 12 post-operative months compared to baseline(3, 6, 9 and 12 months)
- Changes in quantity and class of pain medication use at week 2, 1, 3, 6, 9, 12, and 15 post-operative months comparted to baseline(Week 2, 1, 3, 6, 9, 12, and 15 months)
- Change in Timed Up and Go (TUG) Test for Lower Extremity Amputees through 12 post-operative months compared to baseline(3, 6, 9 and 12 months)
研究者
研究点 (4)
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