<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/NCT04441333</url>
  </required_header>
  <id_info>
    <org_study_id>Aspivix_IUD2019_Pilot</org_study_id>
    <nct_id>NCT04441333</nct_id>
  </id_info>
  <brief_title>Usability, Safety and Efficacy of AspivixTM</brief_title>
  <official_title>Usability, Safety and Efficacy of AspivixTM, an Atraumatic Innovative Uterine Cervical Traction Device: a Pilot Phase Followed by a Comparative Study (Pilot)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aspivix SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aspivix SA</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Limited mobility of the uterine cervix and alignment with the vaginal canal is often required&#xD;
      during insertion of an intrauterine contraceptive device (IUD). Currently, the available&#xD;
      instruments are traumatic tenacula, which could cause pain and bleeding and therefore&#xD;
      represent an obstacle for certain patients to pursue their medical follow-up.&#xD;
&#xD;
      AspivixTM is a new device, which enables atraumatic traction of the cervix while respecting&#xD;
      its specific semi-circular anatomic shape through a system powered by a vacuum chamber.&#xD;
&#xD;
      The aim of our pilot study is to assess the usability, safety and efficacy of the device.&#xD;
&#xD;
      Note: Study is made of 2 phases (pilot phase followed by a comparative phase). Details&#xD;
      regarding comparative study is registered separately.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">December 2, 2020</completion_date>
  <primary_completion_date type="Actual">December 2, 2020</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>
    <intervention_model_description>Pilot study: single-arm non-comparative study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usability and efficacy from the practitioner's perspective: questionnaire</measure>
    <time_frame>Right after the use of the device (right after the end of the procedure to insert the IUD).</time_frame>
    <description>The practitioner will assess the usability and efficacy of the Investigational Device using a 5 point Likert 'Usability and Efficacy Questionnaire'.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant's reported pain: Visual Analogue Scale</measure>
    <time_frame>Before the procedure, during speculum insertion, during AspivixTM vacuum application, during application of cervical traction, during IUD insertion, during AspivixTM release, 5 minutes after the end of the procedure</time_frame>
    <description>Participant's reported pain will be assessed by the patient using a 100-point Visual Analogue Scale (VAS) at specific steps during IUD insertion Minimum and maximum values range from 0 to 100, the higher score being the better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of patient's satisfaction: questionnaire</measure>
    <time_frame>Right after the use of the device (right after the end of the procedure to insert the IUD).</time_frame>
    <description>5 point Likert 'Patient Satisfaction Questionnaire' Minimal to maximal values range from 1 to 5, 1 meaning &quot;disagree&quot; and 5 &quot;agree&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of placement attempts before traction can be applied</measure>
    <time_frame>During the procedure to insert the IUD which should last less than 5 minutes.</time_frame>
    <description>The number of placement attempts before traction of the cervix can be applied will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of spontaneous releases during traction</measure>
    <time_frame>During the procedure to insert the IUD which should last less than 5 minutes.</time_frame>
    <description>The number of spontaneous releases during traction of the cervix will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of bleeding</measure>
    <time_frame>During the procedure to insert the IUD which should last less than 5 minutes.</time_frame>
    <description>To assess bleeding, every buffer will be weighted, and the blank weight subtracted. Weight in mg will be reported in the case report form.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of adverse events</measure>
    <time_frame>During the procedure to insert the IUD which should last less than 5 minutes.</time_frame>
    <description>Safety of the procedure will be assessed by documenting adverse events (description of the adverse events, number of participants)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of device deficiencies</measure>
    <time_frame>During the procedure to insert the IUD which should last less than 5 minutes.</time_frame>
    <description>Safety of the procedure will be assessed by documenting device deficiencies (description of the deficiency)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of new risks</measure>
    <time_frame>During the procedure to insert the IUD which should last less than 5 minutes.</time_frame>
    <description>Safety of the procedure will be assessed by identifying and documenting any new risk.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>IUD Insertion</condition>
  <arm_group>
    <arm_group_label>AspivixTM cervical vacuum tenaculum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AspivixTM cervical vacuum tenaculum</intervention_name>
    <description>Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum</description>
    <arm_group_label>AspivixTM cervical vacuum tenaculum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants older than 18 years&#xD;
&#xD;
          -  Participants presenting at the outpatient clinic for Mirena IUD insertion.&#xD;
&#xD;
          -  Participants able to provide informed consent as documented by signature with at least&#xD;
             24 hours of reflection time&#xD;
&#xD;
          -  Good understanding of written and oral speaking used at the centre where the study&#xD;
             will be carried out.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who are contraindicated for the insertion of the IUD Mirena&#xD;
&#xD;
          -  Participants under use of excessive alcohol, narcotics or benzodiazepines prior to&#xD;
             procedure&#xD;
&#xD;
          -  Participants who do not wish to be informed of a chance discovery&#xD;
&#xD;
          -  Participant receiving anaesthetics prior to IUD insertion procedure&#xD;
&#xD;
          -  Participants on anticoagulant medication&#xD;
&#xD;
          -  Participants under use of an analgesic&#xD;
&#xD;
          -  Previous cervical operation&#xD;
&#xD;
          -  Severe vaginal bleeding&#xD;
&#xD;
          -  Participant previously enrolled in this study&#xD;
&#xD;
          -  Cervix diameter smaller than 26 mm&#xD;
&#xD;
          -  Mullerian anomalies with two cervices&#xD;
&#xD;
          -  Nabothian cyst&#xD;
&#xD;
          -  Cervical myomas&#xD;
&#xD;
          -  Cervical condylomas&#xD;
&#xD;
          -  Squamous intraepithelial lesion (Cervical dysplasia)&#xD;
&#xD;
          -  Cervical endometriosis&#xD;
&#xD;
          -  Cervical tears&#xD;
&#xD;
          -  A well exposed cervix and / or well aligned vaginal and cervical canals where no&#xD;
             traction is required for IUD insertion&#xD;
&#xD;
          -  Other cervical abnormalities (cervical polyp, cervical lesion, or irregularity) which&#xD;
             may contraindicate or complicate IUD insertion&#xD;
&#xD;
          -  Large ectopy, for which it is not possible to find a suitable location near the ectopy&#xD;
             where native tissue is present&#xD;
&#xD;
          -  Large scar tissue, for which it is not possible to find a suitable location near the&#xD;
             scar where native tissue is present&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrice Mathevet, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>DFME CHUV Lausanne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department Women, Mother &amp; Child, University Hospital</name>
      <address>
        <city>Lausanne</city>
        <state>Vaud</state>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>December 10, 2020</last_update_submitted>
  <last_update_submitted_qc>December 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04441333
org study id: Aspivix_IUD2019_Pilot
nct id: NCT04441333
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Limited mobility of the uterine cervix and alignment with the vaginal canal is often required
      during insertion of an intrauterine contraceptive device (IUD). Currently, the available
      instruments are traumatic tenacula, which could cause pain and bleeding and therefore
      represent an obstacle for certain patients to pursue their medical follow-up.

      AspivixTM is a new device, which enables atraumatic traction of the cervix while respecting
      its specific semi-circular anatomic shape through a system powered by a vacuum chamber.

      The aim of our pilot study is to assess the usability, safety and efficacy of the device.

      Note: Study is made of 2 phases (pilot phase followed by a comparative phase). Details
      regarding comparative study is registered separately.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pilot study: single-arm non-comparative study
primary purpose: Other
masking: None (Open Label)
measure: Usability and efficacy from the practitioner's perspective: questionnaire
time frame: Right after the use of the device (right after the end of the procedure to insert the IUD).
description: The practitioner will assess the usability and efficacy of the Investigational Device using a 5 point Likert 'Usability and Efficacy Questionnaire'.
measure: Participant's reported pain: Visual Analogue Scale
time frame: Before the procedure, during speculum insertion, during AspivixTM vacuum application, during application of cervical traction, during IUD insertion, during AspivixTM release, 5 minutes after the end of the procedure
description: Participant's reported pain will be assessed by the patient using a 100-point Visual Analogue Scale (VAS) at specific steps during IUD insertion Minimum and maximum values range from 0 to 100, the higher score being the better outcome.
measure: Assessment of patient's satisfaction: questionnaire
time frame: Right after the use of the device (right after the end of the procedure to insert the IUD).
description: 5 point Likert 'Patient Satisfaction Questionnaire' Minimal to maximal values range from 1 to 5, 1 meaning "disagree" and 5 "agree".
measure: The number of placement attempts before traction can be applied
time frame: During the procedure to insert the IUD which should last less than 5 minutes.
description: The number of placement attempts before traction of the cervix can be applied will be recorded
measure: The number of spontaneous releases during traction
time frame: During the procedure to insert the IUD which should last less than 5 minutes.
description: The number of spontaneous releases during traction of the cervix will be recorded
measure: Assessment of bleeding
time frame: During the procedure to insert the IUD which should last less than 5 minutes.
description: To assess bleeding, every buffer will be weighted, and the blank weight subtracted. Weight in mg will be reported in the case report form.
measure: Assessment of adverse events
time frame: During the procedure to insert the IUD which should last less than 5 minutes.
description: Safety of the procedure will be assessed by documenting adverse events (description of the adverse events, number of participants)
measure: Assessment of device deficiencies
time frame: During the procedure to insert the IUD which should last less than 5 minutes.
description: Safety of the procedure will be assessed by documenting device deficiencies (description of the deficiency)
measure: Identification of new risks
time frame: During the procedure to insert the IUD which should last less than 5 minutes.
description: Safety of the procedure will be assessed by identifying and documenting any new risk.
arm group label: AspivixTM cervical vacuum tenaculum
arm group type: Experimental
description: Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum.
intervention type: Device
intervention name: AspivixTM cervical vacuum tenaculum
description: Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum
arm group label: AspivixTM cervical vacuum tenaculum
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Patrice Mathevet, Prof.
role: Principal Investigator
affiliation: DFME CHUV Lausanne
facility: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No