A Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair

Официальное название

REGEN: A Prospective, Randomized, Open Label Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair

Обзор

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.

Вмешательства

• Устройство Symani® Surgical System
  Robotic-assisted surgery consists of participants who undergo nerve coaptation with the Symani Surgical System, according to the Instruction for Use (IFU). In order for the surgery to be considered a robotic assisted surgery, the participants must be randomized to the RAS group which will include: * Participants where all nerve coaptations were performed entirely with Symani. * Participants who underwent a hybrid procedure, where a coaptation was commenced using Symani but a switch to manual su
• Процедура Manual Surgery
  Manual surgery consists of participants who undergo nerve coaptation through manual techniques by a surgeon using handheld instruments without robotic assistance. In order for the surgery to be considered a manual surgery, the participants must be randomized to the MS group which will include: * Participants where all nerve coaptations were performed entirely manually. * Participants who underwent a hybrid procedure, where a coaptation was commenced using manual suturing but a switch to Symani

Первичные конечные точки

• Two-point discrimination (2PD) test, at 6-months post index procedure. [Срок оценки: From participants index procedure through 6-months post index procedure]
• Intraoperative serious adverse event rate [Срок оценки: The duration of the participants index procedure.]

Вторичные конечные точки (8)

• Two-point discrimination test at 3 and 12-months post index procedure [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From participants index procedure through 3-months, 6-months and 12-months post-index procedure]

Критерии участия

Pre-Operative

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• BG Klinik Ludwigshafen — Ludwigshafen

Идентификаторы

NCT: NCT07084207 · CDC-00146

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗