Expanding use of the Symani robotic system for peripheral nerve repair in the hand

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• BG Klinik Ludwigshafen
  Ludwigshafen, Germany Recruiting

Study contacts

• Study coordinator: Clinical Operations
• Email: clinical.ops@mmimicro.com
• Phone: 8336646276

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.