<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/NCT03810326</url>
  </required_header>
  <id_info>
    <org_study_id>VY-CTS1-01</org_study_id>
    <nct_id>NCT03810326</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome</brief_title>
  <official_title>Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuinvent Innovations Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuinvent Innovations Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Interventional study to evaluate efficacy and safety of an active splint.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 12, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in pain score</measure>
    <time_frame>10 weeks</time_frame>
    <description>Reduction in NRS reported pain score</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CTR device (tradename named Xtend)</intervention_name>
    <description>Non invasive active splint</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients, above 40 years of age.&#xD;
&#xD;
          -  Able to understand and sign informed consent&#xD;
&#xD;
          -  Pain associated with mild to moderate carpal tunnel syndrome in a single wrist&#xD;
&#xD;
          -  Numbness and tingling in the median nerve distribution&#xD;
&#xD;
          -  Nocturnal Numbness&#xD;
&#xD;
          -  Weakness and/or atrophy of the thenar musculature&#xD;
&#xD;
          -  Demonstrate positive Phalen's Test of the affected extremity&#xD;
&#xD;
          -  Demonstrate positive Tinel's Test of the affected extremity&#xD;
&#xD;
          -  Sensory impairment defined as a loss of 2-point discrimination&#xD;
&#xD;
          -  Have recent (within 3 months) electro-diagnostic evidence of Carpal Tunnel Syndrome&#xD;
&#xD;
        Exclusion Criteria:• Currently receiving treatment for carpal tunnel syndrome&#xD;
&#xD;
          -  History of surgical carpal tunnel release&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Diabetes not controlled by medication&#xD;
&#xD;
          -  Radiculopathy i.e., cervical radiculopathy, diabetic radiculopathy&#xD;
&#xD;
          -  Thoracic outlet syndrome&#xD;
&#xD;
          -  Compromised skin integrity&#xD;
&#xD;
          -  Past history of traumatic event, surgery, or congenital impairment of the forearm,&#xD;
             wrist, or hand&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Oleg Dulcart, PHd</last_name>
    <phone>+972-(0)524-262544</phone>
    <email>olegd@tlvmc.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oleg Dulcart</last_name>
      <phone>+9720524262544</phone>
      <phone_ext>+9720524262544</phone_ext>
      <email>olegd@tlvmc.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</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>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03810326
org study id: VY-CTS1-01
nct id: NCT03810326
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Interventional study to evaluate efficacy and safety of an active splint.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction in pain score
time frame: 10 weeks
description: Reduction in NRS reported pain score
arm group label: Intervention
arm group type: Experimental
intervention type: Device
intervention name: CTR device (tradename named Xtend)
description: Non invasive active splint
arm group label: Intervention
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Oleg Dulcart, PHd
phone: +972-(0)524-262544
email: olegd@tlvmc.gov.il
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome
sharing ipd: No