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Clinical Trials/NCT05980767
NCT05980767
Recruiting
Not Applicable

Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial

Epineuron Technologies Inc.2 sites in 1 country26 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuropathy;Peripheral
Sponsor
Epineuron Technologies Inc.
Enrollment
26
Locations
2
Primary Endpoint
Recruitment Rate
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
December 1, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Ulnar neuropathy at the elbow

Exclusion Criteria

  • Peripheral neuropathy outside of nerve of interest
  • Patients with any active implanted device

Outcomes

Primary Outcomes

Recruitment Rate

Time Frame: 1.5 years

Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm

Retention Rate

Time Frame: 1.5 years

Evaluation of study feasibility through the number of participants who complete all study activities

Eligibility Rate

Time Frame: 1.5 years

Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria

Study Sites (2)

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