<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/NCT02239133</url>
  </required_header>
  <id_info>
    <org_study_id>ProVATE PT 103</org_study_id>
    <nct_id>NCT02239133</nct_id>
  </id_info>
  <brief_title>R&amp;D Supporting Pilot Study for the Assessment of the Safety and Effectiveness of the ProVATE (ProTIPI) Vaginal Pessary</brief_title>
  <official_title>Pilot Study for the Evaluation of the ProVATE (ProTIPI) Pessary Designs in the Temporary Management of Pelvic Organ Prolapse (POP) in Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ConTIPI Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ConTIPI Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study includes five (5) main stages: Screening, Enrollment, Size fitting, Usage and&#xD;
      Termination.&#xD;
&#xD;
      Subject screening will be held during visit one (1) and visit two (2) at the clinic.&#xD;
&#xD;
      Initiation and Size fitting:&#xD;
&#xD;
      All eligible subjects will undergo size fitting by a gynecologist / urogynecologist, during&#xD;
      visit 2, to find the suitable size for her. The subject will use the ProVATE device of the&#xD;
      chosen size at the clinic vicinity for about one (1) hour and for 40-80 hours at her home&#xD;
      environment, to confirm that the chosen size is appropriate for the user. Each usage will be&#xD;
      followed by a vaginal examination. In case the investigator will determine that the subject&#xD;
      should be fitted with a different size of the ProVATE device the subject will repeat this&#xD;
      stage with a different device size until the suitable size is confirmed by the investigator.&#xD;
&#xD;
      Usage:&#xD;
&#xD;
      The subject will use the ProVATE device for at least 28 days during a 45 days period, at her&#xD;
      home environment, and fill a usage diary. Each device will be used for at least 24 hours. At&#xD;
      least one (1) follow-up phone call will be held with the subject per a week. After 14 usage&#xD;
      days or following at least two (2) usages (the latest of them) the subject will be scheduled&#xD;
      for vaginal examination at the clinic (visit four (4)).&#xD;
&#xD;
      End Of Use At the end of use the subject will return to the clinic (visit five (5)) for a&#xD;
      vaginal examination and additional activities.&#xD;
&#xD;
      The following questionnaires will be filled at baseline and end of study: Quality Of Life&#xD;
      (QoL) and POP symptoms. Satisfaction and Ease Of Use questionnaires will be filled at the end&#xD;
      of use (visit 5) Up to four (4) ProVATE device models will be tested in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">September 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>Degree of prolapse and POP symptoms following ProVATE device insertion, compared to the degree of prolapse prior to the insertion of the ProVATE device (by vaginal examination)</measure>
    <time_frame>At day 1 - baseline, and following at least 28 and up to 45 days of using the ProVATE vaginal pessary</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>ProVATE vaginal pessary</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The ProVATE device is a disposable, single-use, vaginal pessary for the management of Pelvic Organ Prolapse (&quot;POP&quot;). The ProVATE device is similar to other ring pessaries currently on the market. Its features allow for easy and comfortable insertion and removal by the user herself at her home environment. The ProVATE device is provided in six (6) different sizes and is intended for prescription use only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ProVATE vaginal pessary</intervention_name>
    <arm_group_label>ProVATE vaginal pessary</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females aged 21-80 years&#xD;
&#xD;
          -  Ability to use both hands and insert a device into the vagina&#xD;
&#xD;
          -  Ability to attend the study site as explained by the investigator&#xD;
&#xD;
          -  A symptomatic sensation of vaginal prolapse&#xD;
&#xD;
          -  The subject has the ability to understand the nature of the study and sign the&#xD;
             informed consent&#xD;
&#xD;
          -  On examination, the presence of a vaginal wall prolapse of one or more sites&#xD;
&#xD;
          -  On examination, POP-Q grade 2 - 4 POP is demonstrated&#xD;
&#xD;
          -  A 61-91 mm pessary is well fitted&#xD;
&#xD;
          -  A 61-91 mm pessary is well retained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous inability to accommodate with tampons or vaginal pessaries&#xD;
&#xD;
          -  Subject is currently participating in another clinical study which may directly or&#xD;
             indirectly affect the results of this study&#xD;
&#xD;
          -  Co-morbid condition(s) or severe systemic disease that could limit the subject 's&#xD;
             ability to participate in the study, or impact the scientific integrity of the study&#xD;
&#xD;
          -  Subject is pregnant, or suspected to be pregnant or is planning to be pregnant during&#xD;
             the course of the study&#xD;
&#xD;
          -  Abnormal vaginal bleeding in the past 6 months&#xD;
&#xD;
          -  Previous vaginal surgery during the last 3 months&#xD;
&#xD;
          -  A severely atrophic vagina&#xD;
&#xD;
          -  Existing vaginal or vulvar laceration&#xD;
&#xD;
          -  Symptomatic vaginal infection as determined by physical examination and lab results&#xD;
&#xD;
          -  Symptomatic urinary tract infection as determined by physical examination and lab&#xD;
             results&#xD;
&#xD;
          -  Recurrent urinary tract infections&#xD;
&#xD;
          -  Abnormal cervical cytology&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Site 01</name>
      <address>
        <city>Herzliya</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 02</name>
      <address>
        <city>Herzliya</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 03</name>
      <address>
        <city>ramat HaSharon</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>December 30, 2015</last_update_submitted>
  <last_update_submitted_qc>December 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pelvic Organ Prolapse</keyword>
  <keyword>POP</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/NCT02239133
org study id: ProVATE PT 103
nct id: NCT02239133
lead sponsor: 
has dmc: No
The study includes five (5) main stages: Screening, Enrollment, Size fitting, Usage and
      Termination.

      Subject screening will be held during visit one (1) and visit two (2) at the clinic.

      Initiation and Size fitting:

      All eligible subjects will undergo size fitting by a gynecologist / urogynecologist, during
      visit 2, to find the suitable size for her. The subject will use the ProVATE device of the
      chosen size at the clinic vicinity for about one (1) hour and for 40-80 hours at her home
      environment, to confirm that the chosen size is appropriate for the user. Each usage will be
      followed by a vaginal examination. In case the investigator will determine that the subject
      should be fitted with a different size of the ProVATE device the subject will repeat this
      stage with a different device size until the suitable size is confirmed by the investigator.

      Usage:

      The subject will use the ProVATE device for at least 28 days during a 45 days period, at her
      home environment, and fill a usage diary. Each device will be used for at least 24 hours. At
      least one (1) follow-up phone call will be held with the subject per a week. After 14 usage
      days or following at least two (2) usages (the latest of them) the subject will be scheduled
      for vaginal examination at the clinic (visit four (4)).

      End Of Use At the end of use the subject will return to the clinic (visit five (5)) for a
      vaginal examination and additional activities.

      The following questionnaires will be filled at baseline and end of study: Quality Of Life
      (QoL) and POP symptoms. Satisfaction and Ease Of Use questionnaires will be filled at the end
      of use (visit 5) Up to four (4) ProVATE device models will be tested in this study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Degree of prolapse and POP symptoms following ProVATE device insertion, compared to the degree of prolapse prior to the insertion of the ProVATE device (by vaginal examination)
time frame: At day 1 - baseline, and following at least 28 and up to 45 days of using the ProVATE vaginal pessary
arm group label: ProVATE vaginal pessary
arm group type: Experimental
description: The ProVATE device is a disposable, single-use, vaginal pessary for the management of Pelvic Organ Prolapse ("POP"). The ProVATE device is similar to other ring pessaries currently on the market. Its features allow for easy and comfortable insertion and removal by the user herself at her home environment. The ProVATE device is provided in six (6) different sizes and is intended for prescription use only.
intervention type: Device
intervention name: ProVATE vaginal pessary
arm group label: ProVATE vaginal pessary
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse