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/NCT06036303</url>
    </required_header>
    <id_info>
      <org_study_id>PR00C1945</org_study_id>
      <nct_id>NCT06036303</nct_id>
    </id_info>
    <brief_title>Nasr Fascial Closure: A Novel Device for Fascial Closure in Laparoscopic Surgery</brief_title>
    <official_title>Nasr Fascial Closure: A Novel Device for Fascial Closure in Laparoscopic Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ClinAmygate</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Aswan University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>ClinAmygate</source>
    <oversight_info>
      <has_dmc>Yes</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 study will investigate the efficacy and safety of a new fascial closure device &quot;Nasr&#xD;
        Fascial Closure Device&quot; compared to the Karl Storz Berci Fascial Closure Device 26173AM.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 15, 2023</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>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>duration of port site closure</measure>
      <time_frame>1 day</time_frame>
      <description>Duration in seconds</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of failure of port site</measure>
      <time_frame>1 day</time_frame>
      <description>Rate of failure to close the port site</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of port site infection</measure>
      <time_frame>1 month</time_frame>
      <description>Incidence of infection of the port site</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of port site hernia</measure>
      <time_frame>6 weeks</time_frame>
      <description>Incidence of hernia at the port site</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Cholecystolithiasis</condition>
    <arm_group>
      <arm_group_label>Nasr Fascial Closure Device</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Berci Fascial Closure Device</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Nasr fascial closure device</intervention_name>
      <description>Nasr fascial closure device is a novel device for fascial closure</description>
      <arm_group_label>Nasr Fascial Closure Device</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Berci Fascial Closure Device</intervention_name>
      <description>Berci Fascial Closure Device is a known device for fascial closure</description>
      <arm_group_label>Berci Fascial Closure Device</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age &gt; 18&#xD;
  &#xD;
            -  eligible for Laparoscopic cholecystectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  refused to participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Laparoscopic removal</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cholecystolithiasis</mesh_term>
      <mesh_term>Cholelithiasis</mesh_term>
      <mesh_term>Gallstones</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/NCT06036303
  org study id: PR00C1945
  nct id: NCT06036303
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The study will investigate the efficacy and safety of a new fascial closure device "Nasr
        Fascial Closure Device" compared to the Karl Storz Berci Fascial Closure Device 26173AM.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: duration of port site closure
  time frame: 1 day
  description: Duration in seconds
  measure: Rate of failure of port site
  time frame: 1 day
  description: Rate of failure to close the port site
  measure: Incidence of port site infection
  time frame: 1 month
  description: Incidence of infection of the port site
  measure: Incidence of port site hernia
  time frame: 6 weeks
  description: Incidence of hernia at the port site
  arm group label: Nasr Fascial Closure Device
  arm group type: Experimental
  arm group label: Berci Fascial Closure Device
  arm group type: Active Comparator
  intervention type: Device
  intervention name: Nasr fascial closure device
  description: Nasr fascial closure device is a novel device for fascial closure
  arm group label: Nasr Fascial Closure Device
  intervention type: Device
  intervention name: Berci Fascial Closure Device
  description: Berci Fascial Closure Device is a known device for fascial closure
  arm group label: Berci Fascial Closure Device
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Cholecystolithiasis
  mesh term: Cholelithiasis
  mesh term: Gallstones