Actively Recruiting
A 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 time of nerve injury
- Patient agrees to participate, returns for all follow-ups, and provides written informed consent
- Complete loss of sensation in a specific finger area
- Clinical need for microsurgical nerve repair by end-to-end suturing
- Traumatic transection of one or more digit nerves distal to the carpal tunnel with sensory autonomous areas on finger or thumb tips
- Investigator considers patient suitable for either conventional or robotic-assisted epineural suturing
- Injury treated within 10 days
- Intraoperative confirmation of sensory nerve lesion without a gap and suitable for end-to-end suturing
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Significant cardiovascular, digestive, respiratory, endocrine, liver, or central nervous system disorders or previous mental disorders affecting data collection or protocol compliance
- Currently enrolled in other clinical studies that could impact safety or outcomes
- Belonging to vulnerable populations such as pregnant women or judged ineligible by investigator
- Need for bilateral nerve repair
- Known impaired sensation of the injured finger
- Presence of an implanted pacemaker
- Replantation involving bones
- Intraoperative conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
BG Klinik Ludwigshafen
Ludwigshafen, Germany
Actively Recruiting
Research Team
C
Clinical Operations
CONTACT
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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