PAVmed CarpX Device Clinical Study

PAVmed

Status

Completed

Conditions

Carpal Tunnel Syndrome

Treatments

Device: CarpX Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT03747510

PAVmed CarpX-01-018

Details and patient eligibility

About

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).

Full description

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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