<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/NCT02190825</url>
  </required_header>
  <id_info>
    <org_study_id>CD0040</org_study_id>
    <nct_id>NCT02190825</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of the NeuGuide Device</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pop Medical Solutions</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pop Medical Solutions</source>
  <brief_summary>
    <textblock>
      This study aims to investigate the safety, efficacy, peri and postoperative complications,&#xD;
      and patient satisfaction of sacro-spinous ligament fixation (SSLF) for the management of&#xD;
      pelvic organ prolapse (POP).&#xD;
&#xD;
      Prolapse staging for all subjects in this study will be performed according to the POP-Q&#xD;
      staging system.&#xD;
&#xD;
      Ultrasound examinations for all subjects in this study are subjected to the surgeon need and&#xD;
      will be performed if required by qualified personnel&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">April 1, 2017</completion_date>
  <primary_completion_date type="Actual">April 2016</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>Stage of pelvic floor prolapse as defined by POP-Q score</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Complications (SAE, AE)</measure>
    <time_frame>Up to 6 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NeuGuide device</intervention_name>
    <description>The NeuGuideTM device is indicated for anchoring sutures to ligaments of the pelvic floor</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women ages 18-80 years old&#xD;
&#xD;
          -  POP-Q stage III prolapse or higher&#xD;
&#xD;
          -  Scheduled to undergo a POP Surgery and has agreed to undergo it using the NeuGuideTM&#xD;
             device&#xD;
&#xD;
          -  Patient is willing to return for follow-up evaluation and fill questionnaires as&#xD;
             indicated on study protocol&#xD;
&#xD;
          -  No exclusion criteria fulfilled&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of reproductive tract anomalies&#xD;
&#xD;
          -  Prior pelvic radiation therapy or any malignancy&#xD;
&#xD;
          -  Inability to complete written questionnaires.&#xD;
&#xD;
          -  Women with significant Pelvic Inflammatory Disease (PID) history&#xD;
&#xD;
          -  Women with known allergy to Nickel or Nitinol&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Wolfson Medical Center</name>
      <address>
        <city>Bat Yam</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>January 18, 2018</last_update_submitted>
  <last_update_submitted_qc>January 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</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>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <!-- 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/NCT02190825
org study id: CD0040
nct id: NCT02190825
lead sponsor: 
This study aims to investigate the safety, efficacy, peri and postoperative complications,
      and patient satisfaction of sacro-spinous ligament fixation (SSLF) for the management of
      pelvic organ prolapse (POP).

      Prolapse staging for all subjects in this study will be performed according to the POP-Q
      staging system.

      Ultrasound examinations for all subjects in this study are subjected to the surgeon need and
      will be performed if required by qualified personnel
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Stage of pelvic floor prolapse as defined by POP-Q score
time frame: 6 months
measure: Complications (SAE, AE)
time frame: Up to 6 months
intervention type: Device
intervention name: NeuGuide device
description: The NeuGuideTM device is indicated for anchoring sutures to ligaments of the pelvic floor
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse