Clinical Trials

Inclusion Criteria:

• Male and female patients ages > 18 years or older.
• Male and female patients with a clinical diagnosis of CTS and a CTS-6 score of > 12.43.
• Confirmatory electrodiagnostic testing indicating median neuropathy at the wrist (i.e., consistent with a clinical diagnosis of CTS) or ultrasound findings consistent with median nerve enlargement in the carpal tunnel.43-48.
• Candidate for surgical CTR based on severe and/or refractory symptoms.
• Following discussion of surgical options for CTR, the patient elects to proceed with USCTR.

Exclusion Criteria:

• Inability to complete the informed consent process or outcome questionnaires.
• Previous carpal tunnel release or wrist surgery on the ipsilateral side.
• Previous history of complex regional pain syndrome (CRPS).
• Previous history of upper limb vascular disease (including documented thoracic outlet syndrome) or Raynaud’s phenomenon.
• Traumatic injury to the median nerve or any of its branches on the ipsilateral side.
• Contraindication to proceeding with USCTR based on diagnostic ultrasound.
• Patients who are anticoagulated with an INR >3.0.
• Carpal tunnel injection with corticosteroid within 6 weeks prior to anticipated procedure.