<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/NCT01673360</url>
  </required_header>
  <id_info>
    <org_study_id>PR1102</org_study_id>
    <nct_id>NCT01673360</nct_id>
  </id_info>
  <brief_title>Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices</brief_title>
  <acronym>CAPTURE</acronym>
  <official_title>Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ASTORA Women's Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ASTORA Women's Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To monitor post-market performance through evaluation of short and long-term performance via:&#xD;
&#xD;
        -  Efficacy&#xD;
&#xD;
        -  Safety&#xD;
&#xD;
        -  Patient reported outcomes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As this is a post-market registry on market approved devices, there will be no formal&#xD;
      hypothesis testing. However, points of evaluation will include:&#xD;
&#xD;
        -  Characterize the efficacy of the AMS market approved female pelvic health products using&#xD;
           standard of care outcome measures and validated quality of life questionnaires&#xD;
&#xD;
        -  Characterize the type, severity, and rate of adverse events related to each AMS market&#xD;
           approved female pelvic health product&#xD;
&#xD;
        -  Collect concomitant procedural data related to the pelvic floor area&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor is winding down business operations&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prolapse Efficacy - POP-Q</measure>
    <time_frame>annually, upto 5 years</time_frame>
    <description>Prolapse Endpoints:&#xD;
• POP-Q measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary Incontinence Endpoints</measure>
    <time_frame>annually upto 5 years</time_frame>
    <description>Urinary Incontinence Endpoints:&#xD;
Cough stress test&#xD;
1 hour pad weight test&#xD;
Urodynamics</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">401</enrollment>
  <condition>Female Stress Incontinence</condition>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>Elevate PC</arm_group_label>
    <description>Subjects implanted with Elevate PC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mini Arc Pro</arm_group_label>
    <description>Subjects implanted with Mini Arc Pro</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RetroArc</arm_group_label>
    <description>Subjects implanted with RetroArc</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Elevate PC</intervention_name>
    <description>List of AMS prolapse products</description>
    <arm_group_label>Elevate PC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mini Arc Pro</intervention_name>
    <description>List of AMS Urinary Incontinence devices</description>
    <arm_group_label>Mini Arc Pro</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RetroArc</intervention_name>
    <description>List of AMS Urinary Incontinence devices</description>
    <arm_group_label>RetroArc</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients planned to receive at least one (1) target AMS market approved female pelvic&#xD;
        health product will be considered for inclusion in the registry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must meet all of the following criteria to be considered for inclusion in the&#xD;
             registry.&#xD;
&#xD;
               -  Have a signed Informed Consent Form&#xD;
&#xD;
               -  Have a signed HIPAA Authorization Form or equivalent Patient Privacy Form if&#xD;
                  required outside of the US&#xD;
&#xD;
               -  Is a female at least 18 years of age&#xD;
&#xD;
               -  Is scheduled to receive at least one (1) AMS market approved female pelvic health&#xD;
                  implantable product.&#xD;
&#xD;
               -  Is able and willing to participate in the registry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded from the registry if any one of the following criteria is&#xD;
             met.&#xD;
&#xD;
               -  Patients are contraindicated to receive the target AMS market approved female&#xD;
                  pelvic health product per the product's IFU&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Atlanta Medical Research Institute</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morristown Memorial Hospital</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07962</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Womancare</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seven Hills Women's Health Centers</name>
      <address>
        <city>Cinncinatti</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Female Pelvic Health Center</name>
      <address>
        <city>Newtown</city>
        <state>Pennsylvania</state>
        <zip>18940</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Female Pelvic Medicine Institute of Virginia</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 7W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Windsor Research Office</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8W 5L7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMC Beau Soleil</name>
      <address>
        <city>Montpellier</city>
        <zip>34070</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital BICÊTRE</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>German Pelvic Floor Center, St. Hedwig Hospital</name>
      <address>
        <city>Berlin</city>
        <zip>11 10115</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waldburg-Zeil Kliniken Klinik Tettnang</name>
      <address>
        <city>Tettnang</city>
        <zip>16 88069</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Centre Maribor</name>
      <address>
        <city>Maribor</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pretoria Urology Hospital</name>
      <address>
        <city>Pretoria</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico y Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Beata María Ana de Jesus</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Rio Hortega</name>
      <address>
        <city>Valladolid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Bolton Hospital</name>
      <address>
        <city>Bolton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glasgow - Southern General Hospital</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Slovenia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Belgium</country>
  </removed_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>June 16, 2016</last_update_submitted>
  <last_update_submitted_qc>June 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vaginal repair</keyword>
  <keyword>urinary slings</keyword>
  <keyword>POP</keyword>
  <keyword>SUI</keyword>
  <keyword>prolapse</keyword>
  <keyword>incontinence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</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/NCT01673360
org study id: PR1102
nct id: NCT01673360
lead sponsor: 
has dmc: No
To monitor post-market performance through evaluation of short and long-term performance via:

        -  Efficacy

        -  Safety

        -  Patient reported outcomes
As this is a post-market registry on market approved devices, there will be no formal
      hypothesis testing. However, points of evaluation will include:

        -  Characterize the efficacy of the AMS market approved female pelvic health products using
           standard of care outcome measures and validated quality of life questionnaires

        -  Characterize the type, severity, and rate of adverse events related to each AMS market
           approved female pelvic health product

        -  Collect concomitant procedural data related to the pelvic floor area
observational model: Cohort
time perspective: Prospective
measure: Prolapse Efficacy - POP-Q
time frame: annually, upto 5 years
description: Prolapse Endpoints:
• POP-Q measurement
measure: Urinary Incontinence Endpoints
time frame: annually upto 5 years
description: Urinary Incontinence Endpoints:
Cough stress test
1 hour pad weight test
Urodynamics
arm group label: Elevate PC
description: Subjects implanted with Elevate PC
arm group label: Mini Arc Pro
description: Subjects implanted with Mini Arc Pro
arm group label: RetroArc
description: Subjects implanted with RetroArc
intervention type: Device
intervention name: Elevate PC
description: List of AMS prolapse products
arm group label: Elevate PC
intervention type: Device
intervention name: Mini Arc Pro
description: List of AMS Urinary Incontinence devices
arm group label: Mini Arc Pro
intervention type: Device
intervention name: RetroArc
description: List of AMS Urinary Incontinence devices
arm group label: RetroArc
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
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facility: 
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facility: 
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facility: 
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country: Canada
country: France
country: Germany
country: Slovenia
country: South Africa
country: Spain
country: United Kingdom
country: United States
country: Belgium
responsible party type: Sponsor
mesh term: Urinary Incontinence, Stress
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No