NCT05980767

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

2.1 years

First QC Date

July 14, 2023

Last Update Submit

August 5, 2025

Conditions

Neuropathy;Peripheral

Outcome Measures

Primary Outcomes (3)

  • Eligibility Rate

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

    1.5 years

  • Recruitment Rate

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

    1.5 years

  • Retention Rate

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

    1.5 years

Other Outcomes (7)

  • Electromyography (EMG) Denervation Absence/Presence

    1.5 years

  • Nerve Conduction Study (NCS)

    1.5 years

  • Semmes-Weinstein Monofilament Test

    1.5 years

  • +4 more other outcomes

Study Arms (2)

Experimental Intervention

ACTIVE COMPARATOR

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

Device: Temporary Peripheral Nerve Stimulation System

Control

NO INTERVENTION

Standard of care only.

Interventions

Temporary Peripheral Nerve Stimulation SystemDEVICE

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

Experimental Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ulnar neuropathy at the elbow

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

MeSH Terms

Conditions

Neuritis

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Katelyn So, MHSc

CONTACT

905-206-0466clinops@epineurontech.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2023

First Posted

August 8, 2023

Study Start

November 1, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)