Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
NCT ID: NCT03810326
Last Updated: 2019-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2019-01-12
2020-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
CTR device (tradename named Xtend)
Non invasive active splint
Interventions
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CTR device (tradename named Xtend)
Non invasive active splint
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
Yes
Sponsors
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Yuinvent Innovations Ltd.
INDUSTRY
Responsible Party
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Locations
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Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VY-CTS1-01
Identifier Type: -
Identifier Source: org_study_id
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