RecruitingNot ApplicableNCT05721261

Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation


Sponsor

Epineuron Technologies Inc.

Enrollment

110 participants

Start Date

Aug 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria1

  • Peripheral nerve injury

Exclusion Criteria2

  • Peripheral neuropathy
  • Patients with any active implanted device

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Interventions

DEVICETemporary Peripheral Nerve Stimulation System

Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site.

DEVICESham Temporary Peripheral Nerve Stimulation System

Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.


Locations(15)

University of Florida Health

Gainesville, Florida, United States

Orlando Health Jewett Orthopedic Institute

Orlando, Florida, United States

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States

The Curtis National Hand Center

Baltimore, Maryland, United States

WellSpan Health

York, Pennsylvania, United States

John Peter Smith Hospital

Fort Worth, Texas, United States

University of Alberta Hospital

Edmonton, Alberta, Canada

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Hamilton General Hospital

Hamilton, Ontario, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Roth | McFarlane Hand & Upper Limb Centre

London, Ontario, Canada

Southlake Health

Newmarket, Ontario, Canada

Humber River Health

Toronto, Ontario, Canada

North York General Hospital

Toronto, Ontario, Canada

Trillium Health Partners

Toronto, Ontario, Canada

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NCT05721261


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