xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05980767</url>
    </required_header>
    <id_info>
      <org_study_id>EPNR-CIP-003</org_study_id>
      <nct_id>NCT05980767</nct_id>
    </id_info>
    <brief_title>Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial</brief_title>
    <acronym>SELECT</acronym>
    <official_title>Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Epineuron Technologies Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Federal Economic Development Agency for Southern Ontario (FedDev Ontario)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Epineuron Technologies Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A novel temporary peripheral nerve stimulation system that delivers electrical stimulation&#xD;
        therapy in a cubital tunnel release model will be evaluated for feasibility.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Eligibility Rate</measure>
      <time_frame>1.5 years</time_frame>
      <description>Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recruitment Rate</measure>
      <time_frame>1.5 years</time_frame>
      <description>Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Retention Rate</measure>
      <time_frame>1.5 years</time_frame>
      <description>Evaluation of study feasibility through the number of participants who complete all study activities</description>
    </primary_outcome>
    <other_outcome>
      <measure>Electromyography (EMG) Denervation Absence/Presence</measure>
      <time_frame>1.5 years</time_frame>
      <description>Measurement of electrical activity of a muscle</description>
    </other_outcome>
    <other_outcome>
      <measure>Nerve Conduction Study (NCS)</measure>
      <time_frame>1.5 years</time_frame>
      <description>Measurement of speed of electrical impulse through a nerve</description>
    </other_outcome>
    <other_outcome>
      <measure>Semmes-Weinstein Monofilament Test</measure>
      <time_frame>1.5 years</time_frame>
      <description>Evaluation of sensory recovery through the measurement of a pressure detection threshold</description>
    </other_outcome>
    <other_outcome>
      <measure>Static Two-Point Discrimination</measure>
      <time_frame>1.5 years</time_frame>
      <description>Evaluation of sensory recovery through the measurement of the threshold of discrimination</description>
    </other_outcome>
    <other_outcome>
      <measure>Grip strength</measure>
      <time_frame>1.5 years</time_frame>
      <description>Evaluation of functional recovery through the measurement of maximum grip strength</description>
    </other_outcome>
    <other_outcome>
      <measure>Pinch strength</measure>
      <time_frame>1.5 years</time_frame>
      <description>Evaluation of functional recovery through the measurement of pinch strength</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient Rated Ulnar Nerve Evaluation (PRUNE)</measure>
      <time_frame>1.5 years</time_frame>
      <description>Evaluation of pain and quality of life through patient-reported questionnaire where lower scores indicate lower pain and better quality of life related to the injury</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">26</enrollment>
    <condition>Neuropathy;Peripheral</condition>
    <arm_group>
      <arm_group_label>Experimental Intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Standard of care only.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Temporary Peripheral Nerve Stimulation System</intervention_name>
      <description>Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation.</description>
      <arm_group_label>Experimental Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ulnar neuropathy at the elbow&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Peripheral neuropathy outside of nerve of interest&#xD;
  &#xD;
            -  Patients with any active implanted device&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Marina Manoraj, BEng BioSci</last_name>
      <phone>905-206-0466</phone>
      <email>mmanoraj@epineurontech.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05980767
  org study id: EPNR-CIP-003
  nct id: NCT05980767
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A novel temporary peripheral nerve stimulation system that delivers electrical stimulation
        therapy in a cubital tunnel release model will be evaluated for feasibility.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Eligibility Rate
  time frame: 1.5 years
  description: Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria
  measure: Recruitment Rate
  time frame: 1.5 years
  description: Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm
  measure: Retention Rate
  time frame: 1.5 years
  description: Evaluation of study feasibility through the number of participants who complete all study activities
  measure: Electromyography (EMG) Denervation Absence/Presence
  time frame: 1.5 years
  description: Measurement of electrical activity of a muscle
  measure: Nerve Conduction Study (NCS)
  time frame: 1.5 years
  description: Measurement of speed of electrical impulse through a nerve
  measure: Semmes-Weinstein Monofilament Test
  time frame: 1.5 years
  description: Evaluation of sensory recovery through the measurement of a pressure detection threshold
  measure: Static Two-Point Discrimination
  time frame: 1.5 years
  description: Evaluation of sensory recovery through the measurement of the threshold of discrimination
  measure: Grip strength
  time frame: 1.5 years
  description: Evaluation of functional recovery through the measurement of maximum grip strength
  measure: Pinch strength
  time frame: 1.5 years
  description: Evaluation of functional recovery through the measurement of pinch strength
  measure: Patient Rated Ulnar Nerve Evaluation (PRUNE)
  time frame: 1.5 years
  description: Evaluation of pain and quality of life through patient-reported questionnaire where lower scores indicate lower pain and better quality of life related to the injury
  arm group label: Experimental Intervention
  arm group type: Active Comparator
  description: Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.
  arm group label: Control
  arm group type: No Intervention
  description: Standard of care only.
  intervention type: Device
  intervention name: Temporary Peripheral Nerve Stimulation System
  description: Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation.
  arm group label: Experimental Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Marina Manoraj, BEng BioSci
  phone: 905-206-0466
  email: mmanoraj@epineurontech.com
  responsible party type: Sponsor
  mesh term: Peripheral Nervous System Diseases