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

NCT ID: NCT05980767

Last Updated: 2025-08-08

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Neuropathy;Peripheral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental Intervention

Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.

Group Type ACTIVE_COMPARATOR

Temporary Peripheral Nerve Stimulation System

Intervention Type DEVICE

Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation.

Control

Standard of care only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Temporary Peripheral Nerve Stimulation System

Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Ulnar neuropathy at the elbow

Exclusion Criteria

* Peripheral neuropathy outside of nerve of interest
* Patients with any active implanted device
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal Economic Development Agency for Southern Ontario (FedDev Ontario)

OTHER

Sponsor Role collaborator

Epineuron Technologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status RECRUITING

McMaster University Medical Centre

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Katelyn So, MHSc

Role: CONTACT

905-206-0466

Other Identifiers

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EPNR-CIP-003

Identifier Type: -

Identifier Source: org_study_id

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