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

Study Overview
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Brief Summary
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The MANOS device is a carpal tunnel blade used to perform carpal tunnel release (CTR). CTR is indicated for the treatment of Carpal Tunnel Syndrome when conservative therapy fails. This study is being conducted to evaluate the safety and effectiveness of CTR with the MANOS device.

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Device: MANOS CTR™


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Patient has a prior or current musculoskeletal or neurologic condition that limits strength, motion, or sensation in the affected hand. Patient has a medical condition that precludes the use of anesthetic required for surgery. Patient has an ipsilateral injury or other conditions affecting hand function. Patient has acute CTS resulting from an injury (e.g., fracture). Patient has had previous CTR surgery on the affected hand. Patient has psychiatric history, head injury or any other condition which, in the Investigator's opinion, would prevent patient from complying with post-operative hand therapy or follow-up visits.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MANOS CTR™|The MANOS device is a carpal tunnel blade used to release the transverse carpal ligament in order to provide relief for Carpal Tunnel Syndrome.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gather clinical outcome data on the safety and efficacy of the MANOS Carpal Tunnel Release System. | Clinical outcome data that will be evaluated: Carpal Tunnel Syndrome Questionnaire (CTSQ) Scar sensitivity Hand sensation Grip and pinch strength Hand dexterity | Baseline throughout 12 weeks post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety information will be evaluated by collecting the type, frequency, severity, device, and procedure-relatedness of adverse events. |  | Baseline throughout 12 weeks post-operatively |