NCT07084207 A Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair
| NCT ID | NCT07084207 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MMI (Medical Microinstruments, Inc.) |
| Condition | Nerve Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2026-12-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-12-18 with a primary completion date of 2026-12-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07084207 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Nerve Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07084207 currently recruiting?
Yes, NCT07084207 is actively recruiting participants. Contact the research team at clinical.ops@mmimicro.com for enrollment information.
Where is the NCT07084207 trial being conducted?
This trial is being conducted at Ludwigshafen, Germany.
Who is sponsoring the NCT07084207 clinical trial?
NCT07084207 is sponsored by MMI (Medical Microinstruments, Inc.). The trial plans to enroll 100 participants.