NCT02993276已完成不适用
Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
Polyganics BV16 个研究点 分布在 7 个国家目标入组 73 人开始时间: 2017年4月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 16
- 主要终点
- Visual Analog Scale (VAS) for Pain
研究概览
简要总结
PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT Neuro)
This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.
详细描述
- Device description NEUROCAP®, a bioresorbable nerve capping device based upon the NEUROLAC® nerve guide, is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma. NEUROCAP® is composed of the same biocompatible, bioresorbable copolyester composing the NEUROLAC® nerve guide, Poly(68/32[15/85 D/L] Lactide-Ԑ-Caprolactone) (PLCL).
- Objective This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.
- Study design This post-market surveillance study consists of a cohort study to provide post market surveillance information regarding long-term performance and ease of use of the NEUROCAP® for reduction of the development of peripheral symptomatic end-neuroma in the upper and lower extremity. Sub analyses will be performed regarding demographics and medical background.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
- •Subjects who are able to comply with the follow-up or other requirements.
- •Subjects who are ≥ 18 years old.
- •Subjects with a diagnosis of peripheral symptomatic (end-) neuroma in the upper limb.
- •Subjects with a positive Tinel's sign.
- •Symptomatic neuroma confirmed by pain relief following a 10min ± 2min nerve block with Xylocaine (Lidocaine) - Pain relief defined as minimally 50% reduction in VAS questionnaire score.
- •Subjects that are indicated for surgery to treat symptomatic neuroma.
排除标准
- •Subjects who do not complete the informed consent.
- •Subjects who are not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone or immobilization).
- •Subjects who are unable to comply with the follow-up or other requirements and/or have a life expectancy of less than 24 months.
- •Subjects with congenital neuropathy.
- •Insufficient amount of soft tissue to cover the investigational device, as assessed by the surgeon. Use of the device over a joint is advised against.
- •Subjects who have had historical radiotherapy in the area of the (end-) neuroma.
- •Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32[15/85 D/L] Lactide-ε-Caprolactone) (PLCL).
- •Proximal nerve end > 8mm.
结局指标
主要结局
Visual Analog Scale (VAS) for Pain
时间窗: 2 years
Subjective pain score as indicated by the patient on a scale of 1-100.
次要结局
- Elliot Neuroma questionnaire(2 years)
- QuickDASH(2 years)
- Goals questionnaire(2 years)
- Type of Pain Medication(2 years)
- Recurrence of Neuroma(2 years)
- Amount of Pain Medication(2 years)
研究者
研究点 (16)
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