<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/NCT03294733</url>
  </required_header>
  <id_info>
    <org_study_id>17-002345</org_study_id>
    <nct_id>NCT03294733</nct_id>
  </id_info>
  <brief_title>The Relationship Between Age and Carpal Tunnel Size</brief_title>
  <official_title>The Relationship Between Age and Carpal Tunnel Size</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      Investigators hypothesis is that as human age increases, the size of the carpal tunnel&#xD;
      decreases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be taken to a hand examination room where a portable ultrasound (US)&#xD;
      machine is present. A previously determined wrist will be examined for each of the&#xD;
      participants. The US will be used to obtain measurements of the subjects carpal tunnel and&#xD;
      median nerve at multiple levels in order to define its size.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2017</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 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>
    <intervention_model_description>ultrasound carpal tunnel size on subjects</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Size of carpal tunnel</measure>
    <time_frame>Baseline</time_frame>
    <description>using ultrasound imaging to determine size of carpal tunnel</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Carpal Tunnel</condition>
  <arm_group>
    <arm_group_label>Ultrasound</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Ultrasound wrists to determine carpal tunnel size</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>This ultrasound machine is owned by the department of orthopaedic surgery and is capable of up to 15 MHz image definition with its linear transducer</description>
    <arm_group_label>Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Greater than age 18 having bilateral wrists amenable to ultrasound examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active carpal tunnel syndrome,&#xD;
&#xD;
          -  history of carpal tunnel syndrome&#xD;
&#xD;
          -  any prior arm or hand surgery (including previous carpal tunnel release for any reason&#xD;
             or previous surgery on the volar wrist)&#xD;
&#xD;
          -  distal radius fracture deformity&#xD;
&#xD;
          -  rheumatoid arthritis&#xD;
&#xD;
          -  open wounds or lesions of the hand or forearm&#xD;
&#xD;
          -  known congenital deformities of the upper extremity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter M Murray</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>February 24, 2020</last_update_submitted>
  <last_update_submitted_qc>February 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Peter M. Murray</investigator_full_name>
    <investigator_title>Chair, Orthopedic Department Mayo Clinic Florida</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel 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/NCT03294733
org study id: 17-002345
nct id: NCT03294733
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigators hypothesis is that as human age increases, the size of the carpal tunnel
      decreases.
Participants will be taken to a hand examination room where a portable ultrasound (US)
      machine is present. A previously determined wrist will be examined for each of the
      participants. The US will be used to obtain measurements of the subjects carpal tunnel and
      median nerve at multiple levels in order to define its size.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: ultrasound carpal tunnel size on subjects
primary purpose: Diagnostic
masking: None (Open Label)
measure: Size of carpal tunnel
time frame: Baseline
description: using ultrasound imaging to determine size of carpal tunnel
arm group label: Ultrasound
arm group type: Other
description: Ultrasound wrists to determine carpal tunnel size
intervention type: Procedure
intervention name: Ultrasound
description: This ultrasound machine is owned by the department of orthopaedic surgery and is capable of up to 15 MHz image definition with its linear transducer
arm group label: Ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peter M Murray
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Peter M. Murray
investigator title: Chair, Orthopedic Department Mayo Clinic Florida
mesh term: Carpal Tunnel Syndrome
sharing ipd: No