Expanding use of the Symani robotic system for peripheral nerve repair in the hand
REGEN: A Prospective, Randomized, Open Label Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair
This study will test whether the Symani robotic surgical system can safely and effectively repair recent traumatic sensory nerve cuts in adult fingers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | MMI (Medical Microinstruments, Inc.) Industry-sponsored |
| Locations | 1 site (Ludwigshafen) |
| Trial ID | NCT07084207 on ClinicalTrials.gov |
What this trial studies
Adults with traumatic sensory nerve transections of a finger distal to the carpal tunnel who need end-to-end epineural suturing are enrolled and treated within 10 days of injury. Participants receive either robotic-assisted microsurgical coaptation using the Symani System or conventional manual epineural suturing. The main effectiveness measure is two-point discrimination at six months after the procedure, and the main safety measure is the rate of intraoperative serious adverse events. Procedures and follow-up take place at the study site in Ludwigshafen.
Who should consider this trial
Good fit: Adults 18–70 years with complete loss of a nerve-specific receptive field from a traumatic transection of one or more digit sensory nerves distal to the carpal tunnel, who are candidates for end-to-end suturing and can be treated within 10 days, are ideal candidates.
Not a fit: Patients with injuries not suitable for end-to-end repair, injuries treated more than 10 days after trauma, proximal nerve injuries above the carpal tunnel, motor-only nerve injuries, or who cannot undergo surgery or give consent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the Symani system could improve precision of nerve repairs and lead to better fingertip sensation and functional recovery for patients with recent digit nerve cuts.
How similar studies have performed: Robotic-assisted microsurgery for nerve and soft-tissue repair is an emerging approach with small feasibility and technical success reports, but large studies proving superior functional nerve recovery are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Pre-Operative Inclusion Criteria: 1. Adults, at the time of nerve injury aged from 18 to 70 years 2. 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 3. Complete loss of a nerve-specific receptive field of the finger 4. Patient with a clinical indication for a microsurgical nerve coaptation in nerve injury that can be repaired by end-to-end suturing 5. 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 6. Investigator considers candidate acceptable for either conventional epineural suturing or robotic-assisted epineural suturing 7. The injury was treated within 10 days Exclusion Criteria: 1. Patients who are not capable and/or unwilling to provide informed consent 2. 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. 3. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes 4. Patients belonging to vulnerable populations, such as pregnant women, or patients ineligible to participate for other reasons in the judgement of the investigator 5. Indication for bilateral nerve repair 6. Known impaired sensibility of the injured finger 7. Patients with implanted pacemaker 8. 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
Where this trial is running
Ludwigshafen
- BG Klinik Ludwigshafen — Ludwigshafen, Germany (Recruiting)
Study contacts
- Study coordinator: Clinical Operations
- Email: clinical.ops@mmimicro.com
- Phone: 8336646276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.