<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/NCT04416828</url>
  </required_header>
  <id_info>
    <org_study_id>2019.4</org_study_id>
    <nct_id>NCT04416828</nct_id>
  </id_info>
  <brief_title>Medical Imaging in the Diagnosis of Ganglion Cysts of the Hand</brief_title>
  <official_title>Medical Imaging in the Diagnosis of Ganglion Cysts of the Hand</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Waldfriede Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Waldfriede Hospital</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>
      The aim of this study is to investigate if inexpensive, readily available and portable&#xD;
      wireless ultrasound devices can detect ganglion cysts of the wrist and hand in compare to a&#xD;
      cart-based ultrasound device before surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Size and location of ganglion cysts of the wrist and hand</measure>
    <time_frame>Baseline (pre-surgery)</time_frame>
    <description>Assessment of size in cm and location of the ganglion cyst of the wrist or hand by pre-surgery wireless ultrasound in compare to pre-surgery cart-based ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MRI measure of size and location of ganglion cysts of the wrist and hand</measure>
    <time_frame>Baseline (pre-surgery)</time_frame>
    <description>Assessment of size in cm and location of the ganglion cyst of the wrist or hand by pre-surgery MRI in compare to pre-surgery ultrasonography</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Ganglion Cyst of Both Hands</condition>
  <arm_group>
    <arm_group_label>Suspected ganglion cyst of the wrist or hand</arm_group_label>
    <description>Patients with suspected ganglion cyst of the wrist or hand receive portable wireless ultrasound imaging AND cart-based ultrasound imaging before surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Portable wireless ultrasonography devices</intervention_name>
    <description>Patients with suspected ganglion cyst of the wrist or hand receive portable wireless ultrasound imaging</description>
    <arm_group_label>Suspected ganglion cyst of the wrist or hand</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cart-based ultrasonography device</intervention_name>
    <description>Patients with suspected ganglion cyst of the wrist or hand receive conventional cart-based ultrasound imaging</description>
    <arm_group_label>Suspected ganglion cyst of the wrist or hand</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Ninety male and female patients with ganglion cyst of the wrist or hand planned for surgery&#xD;
        will be recruited at the hand surgery outpatient clinic of the Waldfriede Hospital Berlin.&#xD;
        Patients will be diagnosed with ganglion cyst of the hand/wrist by an experienced hand&#xD;
        surgeon using clinical and MRI data.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Flexor tendon sheath ganglion cyst&#xD;
&#xD;
          -  Dorsal ganglion cyst&#xD;
&#xD;
          -  Palmar ganglion cyst&#xD;
&#xD;
          -  Male and female patients minimum age 18 years&#xD;
&#xD;
          -  MRI of the affected area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, lactation&#xD;
&#xD;
          -  Malignant disease&#xD;
&#xD;
          -  Insufficient mental possibility of cooperation&#xD;
&#xD;
          -  Medical, psychiatric or other conditions that restrict the patient's following&#xD;
             abilities: to interpret the study information, to give informed consent, to adhere to&#xD;
             the rules of the protocol, or to complete the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Lautenbach, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Markus Bock, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nike Kortum</last_name>
    <phone>00493081810201</phone>
    <email>handchirurgie@waldfriede.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Markus Bock, MD</last_name>
    <phone>00493081810201</phone>
    <email>m.bock@waldfriede.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Waldfriede Hospital</name>
      <address>
        <city>Berlin</city>
        <zip>14163</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Markus Bock, Dr. med.</last_name>
      <phone>00493081810201</phone>
      <email>m.bock@waldfriede.de</email>
    </contact>
    <contact_backup>
      <last_name>Martin Lautenbach, Dr. med.</last_name>
      <phone>00493081810201</phone>
      <email>m.lautenbach@waldfriede.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>January 24, 2023</last_update_submitted>
  <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Portable ultrasound</keyword>
  <keyword>Diagnostics</keyword>
  <keyword>Mobile ultrasound</keyword>
  <keyword>Hand held ultrasound</keyword>
  <keyword>Wireless ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ganglion Cysts</mesh_term>
    <mesh_term>Synovial Cyst</mesh_term>
    <mesh_term>Cysts</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/NCT04416828
org study id: 2019.4
nct id: NCT04416828
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate if inexpensive, readily available and portable
      wireless ultrasound devices can detect ganglion cysts of the wrist and hand in compare to a
      cart-based ultrasound device before surgery.
observational model: Cohort
time perspective: Prospective
measure: Size and location of ganglion cysts of the wrist and hand
time frame: Baseline (pre-surgery)
description: Assessment of size in cm and location of the ganglion cyst of the wrist or hand by pre-surgery wireless ultrasound in compare to pre-surgery cart-based ultrasound
measure: MRI measure of size and location of ganglion cysts of the wrist and hand
time frame: Baseline (pre-surgery)
description: Assessment of size in cm and location of the ganglion cyst of the wrist or hand by pre-surgery MRI in compare to pre-surgery ultrasonography
arm group label: Suspected ganglion cyst of the wrist or hand
description: Patients with suspected ganglion cyst of the wrist or hand receive portable wireless ultrasound imaging AND cart-based ultrasound imaging before surgery.
intervention type: Device
intervention name: Portable wireless ultrasonography devices
description: Patients with suspected ganglion cyst of the wrist or hand receive portable wireless ultrasound imaging
arm group label: Suspected ganglion cyst of the wrist or hand
intervention type: Device
intervention name: Cart-based ultrasonography device
description: Patients with suspected ganglion cyst of the wrist or hand receive conventional cart-based ultrasound imaging
arm group label: Suspected ganglion cyst of the wrist or hand
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Lautenbach, MD
role: Study Chair
affiliation: Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
last name: Markus Bock, MD
role: Principal Investigator
affiliation: Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
last name: Nike Kortum
phone: 00493081810201
email: handchirurgie@waldfriede.de
last name: Markus Bock, MD
phone: 00493081810201
email: m.bock@waldfriede.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Sponsor
mesh term: Ganglion Cysts
mesh term: Synovial Cyst
mesh term: Cysts
sharing ipd: No