Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome

Yuinvent Innovations

Status: Unknown

Conditions: Carpal Tunnel Syndrome

Treatments: Device: CTR device (tradename named Xtend)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03810326

VY-CTS1-01

Details and patient eligibility

About

Interventional study to evaluate efficacy and safety of an active splint.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Male or female patients, above 40 years of age.
• Able to understand and sign informed consent
• Pain associated with mild to moderate carpal tunnel syndrome in a single wrist
• Numbness and tingling in the median nerve distribution
• Nocturnal Numbness
• Weakness and/or atrophy of the thenar musculature
• Demonstrate positive Phalen's Test of the affected extremity
• Demonstrate positive Tinel's Test of the affected extremity
• Sensory impairment defined as a loss of 2-point discrimination
• Have recent (within 3 months) electro-diagnostic evidence of Carpal Tunnel Syndrome

Exclusion Criteria:• Currently receiving treatment for carpal tunnel syndrome

• History of surgical carpal tunnel release
• Pregnancy
• Diabetes not controlled by medication
• Radiculopathy i.e., cervical radiculopathy, diabetic radiculopathy
• Thoracic outlet syndrome
• Compromised skin integrity
• Past history of traumatic event, surgery, or congenital impairment of the forearm, wrist, or hand

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Intervention

Experimental group

Treatment:

Device: CTR device (tradename named Xtend)