<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/NCT02209337</url>
  </required_header>
  <id_info>
    <org_study_id>CD-14-005</org_study_id>
    <nct_id>NCT02209337</nct_id>
  </id_info>
  <brief_title>Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse</brief_title>
  <official_title>Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lyra Medical Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lyra Medical Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and&#xD;
      performance of the SRS (Lyra Medical) vaginal mesh in POP patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 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>No device related serious adverse events</measure>
    <time_frame>up to 12 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Minimal rate of device or procedure adverse events (intra and post operative Minimal rate of device or procedure adverse events (intra and post operative complications)</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in POP-Q: points Aa and Ba</measure>
    <time_frame>up to 12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in POP-Q point C</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achieving normal urinary function</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Anterior Vaginal Wall Prolapse</condition>
  <condition>Vaginal Apex/Uterine Prolapse</condition>
  <arm_group>
    <arm_group_label>SRS-I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of SRS-I</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SRS</intervention_name>
    <arm_group_label>SRS-I</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient has signed the informed consent form and is willing to participate in the&#xD;
             clinical study and data collection.&#xD;
&#xD;
          2. Patient age is between 18 and 75 years old&#xD;
&#xD;
          3. POP-Q: Aa and/or Ba is at least -1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient is pregnant or breastfeeding&#xD;
&#xD;
          2. Patient suffering from active infection (on antibiotic therapy)&#xD;
&#xD;
          3. Patient planning vaginal delivery&#xD;
&#xD;
          4. Patient had Previous vaginal mesh surgery&#xD;
&#xD;
          5. Patient is in high risk for surgery (evidence of clinically significant&#xD;
             cardiovascular, renal, hepatic or respiratory diseases).&#xD;
&#xD;
          6. Any condition that in the judgment of the investigators would interfere with the&#xD;
             subject's ability to provide informed consent, comply with study instructions, place&#xD;
             the subject at increased risk, or which might confound interpretation of study&#xD;
             results.&#xD;
&#xD;
          7. Malignancy .&#xD;
&#xD;
          8. Known hypersensitivity to PEEK and polypropylene materials.&#xD;
&#xD;
          9. Participation in another investigational trial that has not completed the primary&#xD;
             endpoint or interferes with study participation.&#xD;
&#xD;
         10. Tendency for hyper-scaring reaction&#xD;
&#xD;
         11. Diagnosed with mental or emotional disturbance.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gil Levi, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayanei HaYeshua Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Szeged</name>
      <address>
        <city>Szeged</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayanei HaYeshua Medical Center</name>
      <address>
        <city>Bnei Brak</city>
        <zip>51544</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asaf HaRofeh Medical Center</name>
      <address>
        <city>Zrifin</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 3, 2014</study_first_submitted>
  <study_first_submitted_qc>August 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 15, 2019</last_update_submitted>
  <last_update_submitted_qc>August 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2019</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>Uterine Prolapse</mesh_term>
    <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/NCT02209337
org study id: CD-14-005
nct id: NCT02209337
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and
      performance of the SRS (Lyra Medical) vaginal mesh in POP patients
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: No device related serious adverse events
time frame: up to 12 month
measure: Minimal rate of device or procedure adverse events (intra and post operative Minimal rate of device or procedure adverse events (intra and post operative complications)
time frame: up to 12 months
measure: Improvement in POP-Q: points Aa and Ba
time frame: up to 12 month
measure: Improvement in POP-Q point C
time frame: up to 12 months
measure: Achieving normal urinary function
time frame: up to 12 months
arm group label: SRS-I
arm group type: Experimental
description: Implantation of SRS-I
intervention type: Device
intervention name: SRS
arm group label: SRS-I
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Gil Levi, Dr.
role: Principal Investigator
affiliation: Mayanei HaYeshua Medical Center
facility: 
facility: 
facility: 
country: Hungary
country: Israel
responsible party type: Sponsor
mesh term: Uterine Prolapse
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse