Actively Recruiting
REGEN: A Prospective, Randomized, Open Label Study to Expand the Use of Symani Surgical System for Peripheral Nerve Repair
Led by MMI (Medical Microinstruments, Inc.) · Updated on 2026-02-03
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Symani Surgical System for safety and effectiveness in repairing sensory nerve injuries in the fingers. This study focuses on adults aged 18 to 70 with traumatic nerve damage distal to the carpal tunnel, treated by nerve suturing. The main goal is to assess nerve function recovery using the two-point discrimination test six months after surgery, while also monitoring serious events during the operation. Participants will be randomly assigned to one of two groups: one receiving nerve repair with the robotic-assisted Symani Surgical System and the other undergoing manual nerve suturing by a surgeon. Both groups include participants who may have hybrid procedures combining robotic and manual techniques. Surgery must occur within 10 days of injury, and the study includes follow-up assessments up to 12 months post-procedure. During the study, participants will return for multiple evaluations measuring nerve sensitivity, hand and thumb strength, finger motion, and functional hand use at 3, 6, and 12 months after surgery. Safety is monitored by tracking serious adverse events during surgery. Overall, the study aims to understand how well robotic-assisted surgery compares to manual surgery for peripheral nerve repair, with participant involvement lasting at least one year after the operation.
CONDITIONS
Brief Title
A Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years at the time of nerve injury
- Willingness to participate, attend all follow-up visits, and provide written informed consent
- Complete loss of sensation in a specific finger area
- Clinical indication for microsurgical nerve coaptation suitable for end-to-end suturing
- Traumatic transection of one or more digit nerves distal to the carpal tunnel with sensory autonomous innervation areas
- Candidate for either conventional or robotic-assisted epineural suturing as judged by the investigator
- Injury treated within 10 days
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Significant cardiovascular, digestive, respiratory, endocrine, liver, central nervous system, or mental disorders affecting data collection or protocol compliance
- Currently enrolled in other investigational clinical studies that may impact safety or outcomes
- Pregnancy or belonging to vulnerable populations as judged by the investigator
- Indication for bilateral nerve repair
- Known impaired sensation of the injured finger
- Presence of implanted pacemaker
- Replantation involving bones
- Intraoperative findings that prevent end-to-end nerve suturing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the participants index procedure
Participants undergo nerve coaptation surgery using either the Symani® Surgical System or manual techniques, followed by immediate post-operative care.
1 surgical procedure visit
Duration - 12 months post index procedure
Participants are monitored for recovery and assessed on sensory and motor function over time.
Visits at 3, 6, and 12 months post-surgery
Trial Site Locations
Total: 1 location
1
BG Klinik Ludwigshafen
Ludwigshafen, Germany
Actively Recruiting
Research Team
C
Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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