A Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair (REGEN)

MMI (Medical Microinstruments, Inc.)

Status: Enrolling

Conditions: Peripheral Nerve Injuries; Nerve Injury

Treatments: Device: Symani® Surgical System; Procedure: Manual Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT07084207

CDC-00146

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Robotic-Assisted Surgery (RAS) group

Active Comparator group

Treatment:

Device: Symani® Surgical System

Manual Surgery (MS) group

Active Comparator group

Treatment:

Procedure: Manual Surgery