Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)

Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) in an office-based setting.

Inclusion Criteria:≥18 years of ageClinical diagnosis of unilateral or bilateral idiopathic CTSCTS-6 score >12 in target hand*Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound*Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection)*Subject agrees to complete follow-up questionnaires over a 24-month periodSubject has a valid smart phone number and/or email address to receive and answer follow-up questionnairesExclusion Criteria:Prior surgery on the target wrist or hand with the exception of (a) trigger finger release or similar minor finger procedure (e.g., digital ganglion cyst removal, foreign body removal) that has clinically recovered, or release for DeQuervain's syndrome (1st dorsal compartment) that has clinically recovered*History of prior surgical CTR in the target hand*History of infection in the target hand*History of prior surgery in the non-target hand, including CTR, within 3 months of enrollment or with persistent symptoms that interfere with normal daily activities or work at the time of consentPlanned surgical or interventional procedure on the contralateral hand within 3 months of the target hand procedure date*Corticosteroid injection in the target hand within 6 weeks of study procedure date*Presence of additional process in the target hand requiring additional intervention beyond carpal tunnel release (e.g. neurolysis, mass removal, tenosynovectomy)*Clinically significant degenerative arthritis of the upper limb (shoulder to hand) on the target side*Clinically significant inflammatory disease (including tenosynovitis) of the upper limb (shoulder to hand) on the target side*Clinically significant trauma or deformity of the upper limb (shoulder to hand) on the target side*Clinically significant vascular disease (including Raynaud's phenomenon) of the upper limb (shoulder to hand) on the target side*Clinically significant neurological disorder (including complex regional pain syndrome) of the upper limb (shoulder to hand) on the target side*Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus)AmyloidosisChronic renal insufficiency requiring dialysisDiabetes not controlled by a stable dose of medicationUncontrolled thyroid diseasePregnant or planning pregnancy in the next 24 monthsWorkers' compensation subjectsInability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirementsSubject has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluationsNote: An asterisk (*) denotes that this criterion must be applied to the target hand for unilateral CTR-US procedures, or to both hands for simultaneous bilateral CTR-US procedures.Clinically significant is defined as likely to interfere with the performance of the procedure in a safe and/or effective manner.