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

Sonex Health

Status: Active, not recruiting

Conditions: Carpal Tunnel Syndrome; CTS

Treatments: Device: Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05675046

90098-TP

Details and patient eligibility

About

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.

Full description

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 reporting the safety and effectiveness of office-based carpal tunnel release with ultrasound guidance (CTR-US) in patients with symptomatic carpal tunnel syndrome (CTS).

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥18 years of age
2. Clinical diagnosis of unilateral or bilateral idiopathic CTS
3. CTS-6 score >12 in target hand*
4. Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound*
5. Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection)*
6. Subject agrees to complete follow-up questionnaires over a 24-month period
7. Subject has a valid smart phone number and/or email address to receive and answer follow-up questionnaires

Exclusion criteria

1. 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*
2. History of prior surgical CTR in the target hand*
3. History of infection in the target hand*
4. 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 consent
5. Planned surgical or interventional procedure on the contralateral hand within 3 months of the target hand procedure date*
6. Corticosteroid injection in the target hand within 6 weeks of study procedure date*
7. Presence of additional process in the target hand requiring additional intervention beyond carpal tunnel release (e.g. neurolysis, mass removal, tenosynovectomy)*
8. Clinically significant degenerative arthritis of the upper limb (shoulder to hand) on the target side*
9. Clinically significant inflammatory disease (including tenosynovitis) of the upper limb (shoulder to hand) on the target side*
10. Clinically significant trauma or deformity of the upper limb (shoulder to hand) on the target side*
11. Clinically significant vascular disease (including Raynaud's phenomenon) of the upper limb (shoulder to hand) on the target side*
12. Clinically significant neurological disorder (including complex regional pain syndrome) of the upper limb (shoulder to hand) on the target side*
13. Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus)
14. Amyloidosis
15. Chronic renal insufficiency requiring dialysis
16. Diabetes not controlled by a stable dose of medication
17. Uncontrolled thyroid disease
18. Pregnant or planning pregnancy in the next 24 months
19. Workers' compensation subjects
20. Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements
21. Subject 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 evaluations

Note: 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 1 patient group

Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device

Experimental group

Description:

Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study.

Treatment:

Device: Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device