<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/NCT03271294</url>
  </required_header>
  <id_info>
    <org_study_id>20160000</org_study_id>
    <nct_id>NCT03271294</nct_id>
  </id_info>
  <brief_title>Prospective Performance Analysis of the Exair(TM) Prolapse Repair System in the Treatment of Pelvic Organ Prolapse</brief_title>
  <official_title>Prospective Performance Analysis of the Exair(TM) Prolapse Repair System in the Treatment of Pelvic Organ Prolapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michigan Institution of Women's Health PC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Coloplast A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Michigan Institution of Women's Health PC</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to assess the role of the Exair transvaginal mesh system to correct&#xD;
      pelvic organ prolapse from a subjective and objective standpoint. Subjects treated with the&#xD;
      Exair transvaginal mesh for prolapse between June 2013 and August 2015 was analyzed. Subjects&#xD;
      with uterine prolapse underwent vaginal mesh hysteropexy. There were no hysterectomies done&#xD;
      for uterine prolapse in this study. A composite score that included subjective criteria of&#xD;
      absence of a bothersome bulge, no prolapse below the hymen and no retreatment was used to&#xD;
      assess success.Transvaginal Exair mesh hysteropexy offers a good option for the management of&#xD;
      large uterine prolapses precluding the need for a hysterectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 19, 2013</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Exair transvaginal mesh procedure success in anatomy and function at 1 year</measure>
    <time_frame>1 year</time_frame>
    <description>Subjects who underwent the Exair transvaginal mesh surgery were followed post-operatively to determine mesh procedure success at 12 months. A composite score that included subjective criteria of absence of a bothersome bulge, no prolapse below the hymen and no retreatment was used to assess success. Subjects treated with the Exair transvaginal mesh for prolapse between June 2013 and August 2015 was analyzed. The aim of the study was to assess the role of the Exair transvaginal mesh system to correct pelvic organ prolapse from a subjective and objective standpoint.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>Exair transvaginal mesh surgery</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a prospective study done in 80 consecutive subjects who underwent the Exair transvaginal mesh surgery from June 2013 to August 2015. The subjects were followed at 4 weeks, 6 months and 12 months post-operatively. All eligible subjects underwent a detailed urogynecologic history and examination including a Pelvic Organ Prolapse Quantification system assessment (POP-Q).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Exair Transvaginal Mesh</intervention_name>
    <description>Exair transvaginal mesh system for the treatment of pelvic organ prolapse</description>
    <arm_group_label>Exair transvaginal mesh surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects desiring surgery for stage II or greater prolapse on the Pelvic Organ&#xD;
             Prolapse Quantification System Assessment (POP-Q) and symptoms specific to pelvic&#xD;
             organ prolapse mainly bothersome perception of a vaginal bulge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any physical or mental limitation that precluded their participation or inability to&#xD;
             give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Michigan Institution of Women's Health PC</investigator_affiliation>
    <investigator_full_name>Salil Khandwala MD</investigator_full_name>
    <investigator_title>Director of Urogynecology</investigator_title>
  </responsible_party>
  <keyword>pelvic organ prolapse</keyword>
  <keyword>Exair</keyword>
  <keyword>Transvaginal mesh</keyword>
  <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/NCT03271294
org study id: 20160000
nct id: NCT03271294
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of the study was to assess the role of the Exair transvaginal mesh system to correct
      pelvic organ prolapse from a subjective and objective standpoint. Subjects treated with the
      Exair transvaginal mesh for prolapse between June 2013 and August 2015 was analyzed. Subjects
      with uterine prolapse underwent vaginal mesh hysteropexy. There were no hysterectomies done
      for uterine prolapse in this study. A composite score that included subjective criteria of
      absence of a bothersome bulge, no prolapse below the hymen and no retreatment was used to
      assess success.Transvaginal Exair mesh hysteropexy offers a good option for the management of
      large uterine prolapses precluding the need for a hysterectomy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Exair transvaginal mesh procedure success in anatomy and function at 1 year
time frame: 1 year
description: Subjects who underwent the Exair transvaginal mesh surgery were followed post-operatively to determine mesh procedure success at 12 months. A composite score that included subjective criteria of absence of a bothersome bulge, no prolapse below the hymen and no retreatment was used to assess success. Subjects treated with the Exair transvaginal mesh for prolapse between June 2013 and August 2015 was analyzed. The aim of the study was to assess the role of the Exair transvaginal mesh system to correct pelvic organ prolapse from a subjective and objective standpoint.
arm group label: Exair transvaginal mesh surgery
arm group type: Other
description: This is a prospective study done in 80 consecutive subjects who underwent the Exair transvaginal mesh surgery from June 2013 to August 2015. The subjects were followed at 4 weeks, 6 months and 12 months post-operatively. All eligible subjects underwent a detailed urogynecologic history and examination including a Pelvic Organ Prolapse Quantification system assessment (POP-Q).
intervention type: Device
intervention name: Exair Transvaginal Mesh
description: Exair transvaginal mesh system for the treatment of pelvic organ prolapse
arm group label: Exair transvaginal mesh surgery
criteria: 
gender: Female
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Michigan Institution of Women's Health PC
investigator full name: Salil Khandwala MD
investigator title: Director of Urogynecology
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse