A Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMMI (Medical Microinstruments, Inc.)
About this trial
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
Qualifiers
Adults, at the time of nerve injury aged from 18 to 70 years
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
Complete loss of a nerve-specific receptive field of the finger
Patient with a clinical indication for a microsurgical nerve coaptation in nerve injury that can be repaired by end-to-end suturing
Disqualifiers
Patients who are not capable and/or unwilling to provide informed consent
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.
Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes
Patients belonging to vulnerable populations, such as pregnant women, or patients ineligible to participate for other reasons in the judgement of the investigator
Trial design
Treatments tested in this trial
- Symani® Surgical System
- Manual Surgery
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov