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 suturing occurred during the procedure
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 occurred during the procedure.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Two-point discrimination (2PD) test, at 6-months post index procedure. — From participants index procedure through 6-months post index procedure The primary effectiveness endpoint is the two-point discrimination (2PD) test, at 6-months post index procedure.
The two-point discrimination test is a sensory test used to assess the ability of the patient to distinguish between two distant points of touch on the skin. The test measures the minimum distance between two stimulus points on the skin, which are perceived as distinct points. This endpoint will be evaluated at 6-months post index procedure.
Intraoperative serious adverse event rate — The duration of the participants index procedure. The primary safety endpoint is the intraoperative serious adverse event rate.
The incidence of SAEs occurring during the intra-operative period will be presented. In addition, each participant will be categorized as 'had any SAEs in the intra-operative period' Yes or No. The proportion of participants who experienced any SAEs in the intra-operative period will be presented with exact confidence limits. The difference between groups will also be presented with exact confidence limits.
Trial sites (1)
Facility
City
Region
Status
BG Klinik Ludwigshafen
Ludwigshafen
Germany
Recruiting
More MMI (Medical Microinstruments, Inc.) trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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