REGEN: A Prospective, Randomized, Open Label Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Two-point discrimination (2PD) test, at 6-months post index procedure.
研究概览
简要总结
The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical nerve coaptation, following nerve injuries to the hand.
This study will include participants with traumatic sensory nerve lesions of a finger nerve distal to the carpal tunnel who are treated with nerve suturing.
The primary effectiveness endpoint is the two-point discrimination (2PD) test, at 6-months post index procedure.
The primary safety endpoint is the intraoperative serious adverse event rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-Operative
- •Inclusion Criteria:
- •Adults, at the time of nerve injury aged from 18 to 70 years
- •Patient agrees to participate in the study, returns for all required follow-up visits, and has willingly provided written informed consent after receiving all information related to the study and its requirements
- •Complete loss of a nerve-specific receptive field of the finger
- •Patient with a clinical indication for a microsurgical nerve coaptation in nerve injury that can be repaired by end-to-end suturing
- •Patient with traumatic transection of one or more digit nerves distal to the carpal tunnel with sensory autonomous innervation areas on the finger or thumb tips
- •Investigator considers candidate acceptable for either conventional epineural suturing or robotic-assisted epineural suturing
- •The injury was treated within 10 days
排除标准
- •Patients who are not capable and/or unwilling to provide informed consent
- •Clinically significant cardiovascular, digestive, respiratory, endocrine, liver or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators' discretion.
- •Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
- •Patients belonging to vulnerable populations, such as pregnant women, or patients ineligible to participate for other reasons in the judgement of the investigator
- •Indication for bilateral nerve repair
- •Known impaired sensibility of the injured finger
- •Patients with implanted pacemaker
- •Replantation which includes bones
- •Intra-Operative Inclusion Criteria
- •Individuals will be included in the study if the following criteria are met intraoperatively:
- •1. Verification of a sensory nerve lesion without a gap and presence of a nerve that could be sutured in end-to-end fashion Intra-Operative Exclusion Criteria
- •Individuals will be excluded from participating in this study if any of the following criteria are met intraoperatively:
- •1. Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would
研究组 & 干预措施
Robotic-Assisted Surgery (RAS) group
干预措施: Symani® Surgical System (Device)
Manual Surgery (MS) group
干预措施: Manual Surgery (Procedure)
结局指标
主要结局
Two-point discrimination (2PD) test, at 6-months post index procedure.
时间窗: From participants index procedure through 6-months post index procedure
The primary effectiveness endpoint is the two-point discrimination (2PD) test, at 6-months post index procedure. The two-point discrimination test is a sensory test used to assess the ability of the patient to distinguish between two distant points of touch on the skin. The test measures the minimum distance between two stimulus points on the skin, which are perceived as distinct points. This endpoint will be evaluated at 6-months post index procedure.
Intraoperative serious adverse event rate
时间窗: The duration of the participants index procedure.
The primary safety endpoint is the intraoperative serious adverse event rate. The incidence of SAEs occurring during the intra-operative period will be presented. In addition, each participant will be categorized as 'had any SAEs in the intra-operative period' Yes or No. The proportion of participants who experienced any SAEs in the intra-operative period will be presented with exact confidence limits. The difference between groups will also be presented with exact confidence limits.
次要结局
- Two-point discrimination test at 3 and 12-months post index procedure(From participants index procedure through 3-months and 12-months post-index procedure)
- Ten Test on sensitivity at 3, 6 and-12 months post index procedure(From participants index procedure through 3-months and 12-months post-index procedure)
- Sensory reinnervation assessment (Semmes-Weinstein monofilament method) at 3, 6 and-12 months post index procedure(From participants index procedure through 3-months, 6-months and 12-months post-index procedure)
- Gross hand strength assessment (Jamar Dynamometer) at 3, 6 and 12-months after post procedure(From participants index procedure through 3-months, 6-months and 12-months post-index procedure)
- Thumb strength assessment (Jamar Dynamometer) at 3, 6 and 12-months post index procedure(From participants index procedure through 3-months, 6-months and 12-months post-index procedure)
- Range of motion of the injured finger in flexion and extension in comparison with the unaffected side at 3, 6 and 12-months post index procedure(From participants index procedure through 3-months, 6-months and 12-months post-index procedure)
- Kapandji Score at 3, 6 and 12-months after post procedure(From participants index procedure through 3-months, 6-months and 12-months post-index procedure)
- DASH questionnaire at 3, 6 and 12-months post index procedure(From participants index procedure through 3-months, 6-months and 12-months post-index procedure)