<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/NCT04406077</url>
  </required_header>
  <id_info>
    <org_study_id>0117-17-HYMC</org_study_id>
    <nct_id>NCT04406077</nct_id>
  </id_info>
  <brief_title>The Use of Ligasure (r) for Hydrocelectomy Surgery</brief_title>
  <official_title>The Use of Ligasure (r) for Cutting and Coagulations of Tissues in Hydrocelectomy Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</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>
      Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain,&#xD;
      with interfering with the normal testes function. however, during activity, this can&#xD;
      interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I&#xD;
      surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for&#xD;
      cutting and coagulating tissues during hydrocelectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain,&#xD;
      with interfering with the normal testes function. however, during activity, this can&#xD;
      interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I&#xD;
      surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for&#xD;
      cutting and coagulating tissues during hydrocelectomy. during the study, males, 18 - 81 who&#xD;
      suffer from hydrocele underwent hydrocelectomy using Ligasure (20 cm) without using sutures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2018</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</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>resolution of hydrocele</measure>
    <time_frame>Three weeks after the surgery</time_frame>
    <description>The patients will undergo full urological physical exam to screen for signs of hydrocele. The testes size and manual palpation will be included in the assessment.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Hydrocele</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients suffering from hydrocele, underwent treatment using Ligasure device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ligasure</intervention_name>
    <description>Using ligasure to treat hydrocele</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 - 81 males&#xD;
&#xD;
          -  Diagnosed with unilateral hydrocele&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral hydrocele&#xD;
&#xD;
          -  infected hydrocele&#xD;
&#xD;
          -  hydrocele secondary to tumor&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>81 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hillel Yaffe MC,</name>
      <address>
        <city>Hadera</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</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>Testicular Hydrocele</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/NCT04406077
org study id: 0117-17-HYMC
nct id: NCT04406077
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain,
      with interfering with the normal testes function. however, during activity, this can
      interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I
      surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for
      cutting and coagulating tissues during hydrocelectomy.
Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain,
      with interfering with the normal testes function. however, during activity, this can
      interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I
      surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for
      cutting and coagulating tissues during hydrocelectomy. during the study, males, 18 - 81 who
      suffer from hydrocele underwent hydrocelectomy using Ligasure (20 cm) without using sutures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: resolution of hydrocele
time frame: Three weeks after the surgery
description: The patients will undergo full urological physical exam to screen for signs of hydrocele. The testes size and manual palpation will be included in the assessment.
arm group label: Intervention
arm group type: Experimental
description: Patients suffering from hydrocele, underwent treatment using Ligasure device.
intervention type: Device
intervention name: Ligasure
description: Using ligasure to treat hydrocele
arm group label: Intervention
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 81 Years
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Testicular Hydrocele
sharing ipd: No