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A Clinical Study Evaluating the Safety and Effectiveness of the Ultrasound-guided Non-incisional Carpal Tunnel Release with Smartwire ® ; Multicenter Randomized Controlled Trial Study

A Clinical Study Evaluating the Safety and Effectiveness of the Ultrasound-guided Non-incisional Carpal Tunnel Release with Smartwire ® ; Multicenter Randomized Controlled Trial Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010223
Enrollment
80
Registered
2025-02-21
Start date
2025-02-28
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Study participants will be randomly assigned in a 1:1 ratio to one of two groups: (1) ultrasound-guided non-incisional carpal tunnel release using Smartwire® or (2) ultrasound-guid

Sponsors

The Catholic University of Korea, Incheon St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Individuals diagnosed with carpal tunnel syndrome based on clinical symptoms and findings from nerve conduction studies or ultrasound examinations. - Individuals who have not responded to or experienced insufficient effects from conservative treatments for carpal tunnel syndrome, such as physical therapy or medication.

Exclusion criteria

Exclusion criteria: - Individuals with a history of prior transverse carpal ligament release. - Individuals with other identifiable causes of carpal tunnel syndrome symptoms on ultrasound examination (e.g., cysts, tumors). - Individuals with cognitive or sensory impairments that prevent accurate pain assessment. - Individuals unable to cooperate with evaluation, treatment, or follow-up procedures. - Pregnant or breastfeeding individuals. - Individuals taking anticoagulant medications with a risk of bleeding. - Individuals with muscle weakness or atrophy that necessitates surgical treatment. - Individuals deemed unsuitable for the clinical trial by the investigator's judgment. - Individuals who have participated in another clinical trial within 3 months prior to the start of this trial.

Design outcomes

Primary

MeasureTime frame
Korean-Boston Carpal Tunnel Syndrome Questionnaire (symptom specific scale, functional status scale)

Secondary

MeasureTime frame
NRS (Numerical Rating Scale)

Countries

Korea, Republic of

Contacts

Public ContactKyung Eun Nam

The Catholic University of Korea, Seoul St. Mary's Hospital

eun840209@naver.com+82-2-2258-1730

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026