Status:
COMPLETED
Feasibility Study of a Temporary Peripheral Nerve Stimulator
Lead Sponsor:
Epineuron Technologies Inc.
Conditions:
Nerve Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.
Eligibility Criteria
Inclusion
- Are between 18-65 years old
- Have a Sunderland II-V peripheral nerve injury of the upper extremity
- Are receiving surgery within 14 days of injury
Exclusion
- Nerve plexus injuries (e.g. brachial plexus)
- Nerve gap requiring graft/conduit, or extreme joint flexion
- Polyneuropathies
- Cognitive impairment and non-English-speaking
- Uncontrolled diabetes
- Surgical intervention \> 14 days of injury
- Co-enrollment in another clinical trial
- Pregnant women
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04732936
Start Date
April 1 2021
End Date
June 21 2023
Last Update
July 13 2023
Active Locations (3)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2
2
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N3Z5
3
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N4A6