Evaluation of the MANOS Carpal Tunnel Release System in Patients With Carpal Tunnel Syndrome

Inclusion Criteria

• •Patient is scheduled to undergo carpal tunnel release surgery.
• •Patient has chronic Carpal Tunnel Syndrome with persistent symptoms despite non-operative treatment, or refusal of non-operative treatment, with one or more of the following: splinting, NSAIDs or corticosteroid injections.
• •Carpal Tunnel Syndrome must be confirmed by positive results of Electromyography (EMG) and Nerve Conduction Velocity (NCV) tests.
• •Patient is a male or non-pregnant, non-lactating female.
• •Patient is 18-75 years of age, inclusive.
• •Female patients of child-bearing potential, including those who have had a tubal ligation, but excluding those who have not experienced a menstrual period for at least two years, must have a negative urine pregnancy test at Screening.
• •Patient must voluntarily provide written, informed consent.