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A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | Experimental |
| |
| Sham treatment | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporary Peripheral Nerve Stimulation System | Device | Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory recovery | 6 months | |
| Cumulative incidence of adverse events | 6 months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tracy Cameron, PhD | Contact | 905-206-0466 | tcameron@epineurontech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Health | Recruiting | Gainesville | Florida | 32608 | United States |
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| Sham Temporary Peripheral Nerve Stimulation System | Device | Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation. |
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| Orlando Health Jewett Orthopedic Institute | Recruiting | Orlando | Florida | 32806 | United States |
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| Louisiana State University Health Sciences Center | Recruiting | New Orleans | Louisiana | 70112 | United States |
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| The Curtis National Hand Center | Completed | Baltimore | Maryland | 21218 | United States |
| WellSpan Health | Completed | York | Pennsylvania | 17403 | United States |
| John Peter Smith Hospital | Recruiting | Fort Worth | Texas | 76104 | United States |
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| University of Alberta Hospital | Completed | Edmonton | Alberta | Canada |
| Saint John Regional Hospital | Recruiting | Saint John | New Brunswick | Canada |
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| Hamilton General Hospital | Recruiting | Hamilton | Ontario | Canada |
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| St. Joseph's Healthcare Hamilton | Recruiting | Hamilton | Ontario | Canada |
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| Roth | McFarlane Hand & Upper Limb Centre | Active, not recruiting | London | Ontario | Canada |
| Southlake Health | Recruiting | Newmarket | Ontario | Canada |
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| Humber River Health | Recruiting | Toronto | Ontario | Canada |
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| North York General Hospital | Recruiting | Toronto | Ontario | Canada |
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| Trillium Health Partners | Recruiting | Toronto | Ontario | Canada |
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