About this trial
Last updated 5 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 5 years ago
What is this trial about?
What are the participation requirements?
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