PAVmed CarpX Device Clinical Study

Study Overview
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Brief Summary
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To study the safety and feasibility of the CarpX device to divide and release the transverse carpal ligament in order to provide relief for Carpal Tunnel Syndrome (CTS).

Detailed Description
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This is a prospective, single center, single arm, study of the CarpX device for treatment of carpel tunnel syndrome. Patients will be followed for up to 30 days post procedure.

Official Title
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Prospective, Single-Center, Single Arm, Feasibility Study of the PAVmed CarpX Device for the Treatment of Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Device: CarpX Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is > 18 years old Patient is scheduled to undergo carpal tunnel release surgery Patient has failed to respond to conservative treatment of CTS CTS confirmed by strong clinical signs and positive Nerve Conduction Velocity (NCV) test Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures Patient is willing and able to complete follow-up requirements Exclusion Criteria: Patient has a prior or current musculoskeletal or neurologic condition that limits strength, motion, or sensation in the affected hand that is unrelated to carpal tunnel syndrome. Patient with stiff wrist, suspected space occupying lesions or other anatomic abnormalities of the forearm, wrist or hand or other concerns related to patient anatomy such as small wrist and/or thin skin Prior invasive treatment of the hand or wrist for disease processes such as De Quervain's syndrome, arthritic wrist etc. on the intended treatment side Previous trauma/fracture or other anatomic abnormalities of the forearm, wrist or hand on the intended treatment side 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 severe chronic median nerve neuropathy shown by the EMG and NCS that shows denervation of the thenar muscle Active local or systemic infection Known allergy to any device component Known severe allergy to contrast reagent that cannot be managed with premedication Any significant medical condition(s) that would place patient at excessive risk for surgery such as: known bleeding disorder including thrombocytopenia (platelet count < 80,000), thrombasthenia, hemophilia or Von Willebrand's disease, unstable cardiac disease, renal failure or uncontrolled diabetes Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from fully participating Women who are pregnant

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CarpX Device<br>Transverse carpal ligament release with CarpX Device | Device: CarpX Device<br>* Transverse carpal ligament release with CarpX Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Safety defined as freedom from Serious Adverse Events probably or definitely related to the CarpX device resulting in significant morbidity. | Freedom from Serious Adverse Events probably or definitely related to the CarpX device resulting in significant morbidity. | Through 30-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Technical Success: defined as the ability of the CarpX Device to perform complete division of the transverse carpel ligament. | Defined as the ability of the CarpX Device to perform complete division of the transverse carpel ligament. | Through 30-day |