TISSIUM's Nerve Coaptation Device First-in-Human Clinical Trial

A Prospective, Multicenter, Single-arm Clinical Trial Evaluating Safety and Performance of TISSIUMTM Nerve Coaptation Device for the Repair of Digital Nerve Discontinuities Where Gap Closure Can be Achieved by Flexion of the Extremity.

The purpose of this study is to collect initial safety and device performance data of the TISSIUM's nerve coaptation device for the sutureless repair of digital nerve injuries of the hand in which there has been no substantial loss of nerve tissue. Additional clinical measures that assess device performance, use, and patient reported outcomes will be collected to guide future study design and potential device modifications.

Inclusion Criteria:

• Patient undergoing a repair of a proper digital nerve of the hand;
• 100% transection injury to the nerve under repair;
• Gap closure between the nerve ends can be achieved by flexion of the extremity without excessive tension;
• Clean surgical wound with sufficient healthy soft tissue that enables primary closure without adjunctive soft tissue procedures;
• Patient willing and able to provide a signed Patient Informed Consent Form;
• Patient willing and able to follow the study instructions and likely to complete all required study procedures and visits.

Exclusion Criteria:

• Patient has a known allergy to the constituent polymer of the investigational device;
• Patient has a documented diagnosis of peripheral neuropathy;
• Patient has a history of neuropathic pain;
• Patient has a history of injury to the nerve being studied;
• Patient has is missing the contralateral digit or with a history of injury to the contralateral digit (comparison control area);
• Patient is pregnant or nursing
• Any patient with a diagnosis of type 1 Diabetes Mellitus;