<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/NCT04441281</url>
  </required_header>
  <id_info>
    <org_study_id>Aspivix_IUD2019_Comparative</org_study_id>
    <nct_id>NCT04441281</nct_id>
  </id_info>
  <brief_title>Usability, Safety and Efficacy of AspivixTM (Comparative Study)</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 (Comparative)</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 comparative study is to assess the patient's pain and bleeding using the&#xD;
      AspivixTM device in comparison with a commonly used single-tooth tenaculum (Pozzi forceps).&#xD;
      Additionally, the comparative study aims to assess and compare the safety of the AspivixTM&#xD;
      device with the single-tooth tenaculum (Pozzi forceps).&#xD;
&#xD;
      Note: Study is made of 2 phases (pilot phase followed by a comparative phase). Details&#xD;
      regarding pilot study is registered separately.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2021</start_date>
  <completion_date type="Actual">February 15, 2022</completion_date>
  <primary_completion_date type="Actual">February 14, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Single-blinded - Participants will be blinded towards the intervention used. Additionally, the type of device used will only be revealed to the practitioner after randomization, immediately prior IUD insertion.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient-reported pain: Visual Analogic Scale</measure>
    <time_frame>Before the procedure</time_frame>
    <description>Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-reported pain: Visual Analogic Scale</measure>
    <time_frame>During speculum insertion</time_frame>
    <description>Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-reported pain: Visual Analogic Scale</measure>
    <time_frame>During AspivixTM / standard tenaculum application</time_frame>
    <description>Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-reported pain: Visual Analogic Scale</measure>
    <time_frame>During application of cervical traction</time_frame>
    <description>Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-reported pain: Visual Analogic Scale</measure>
    <time_frame>During IUD insertion</time_frame>
    <description>Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-reported pain: Visual Analogic Scale</measure>
    <time_frame>During AspivixTM / standard tenaculum release</time_frame>
    <description>Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-reported pain: Visual Analogic Scale</measure>
    <time_frame>5 minutes after the end of the procedure</time_frame>
    <description>Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.</description>
  </primary_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>number of placement attempts before traction can be applied 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</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 the efficacy of the investigational device and its comparator by the practitioner</measure>
    <time_frame>During the procedure to insert the IUD which should last less than 5 minutes.</time_frame>
    <description>5 point Likert 'Efficacy Questionnaire' will be used. 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>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)</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>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>IUD Insertion</condition>
  <arm_group>
    <arm_group_label>Single-tooth tenaculum (Pozzi forceps)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the control arm, a single-tooth tenaculum, Pozzi forceps, used during routine IUD insertion, is employed to hold and stabilize the cervix.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AspivixTM cervical vacuum tenaculum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the experimental arm, the investigational AspivixTM cervical vacuum tenaculum is employed to hold and stabilize the cervix.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Traction of the cervix for IUD insertion</intervention_name>
    <description>Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD).</description>
    <arm_group_label>AspivixTM cervical vacuum tenaculum</arm_group_label>
    <arm_group_label>Single-tooth tenaculum (Pozzi forceps)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants older than 18 years&#xD;
&#xD;
          -  Participants presenting at the outpatient clinic IUD insertion of Mirena (BAYER),&#xD;
             Kyleena (BAYER), Jaydess (BAYER), NOVAT 380 (BAYER), NT Cu380 mini (MONALISA), NT&#xD;
             Cu380 (MONALISA), CuT 380A (MONALISA) or CuT 380A QL (MONALISA).&#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 (BAYER),&#xD;
             Kyleena (BAYER), Jaydess (BAYER), NOVAT 380 (BAYER), NT Cu380 mini (MONALISA), NT&#xD;
             Cu380 (MONALISA), CuT 380A (MONALISA) or CuT 380A QL (MONALISA).&#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 (&lt; 12 hours)&#xD;
&#xD;
          -  Previous cervical operation&#xD;
&#xD;
          -  Severe vaginal bleeding of unknown origin&#xD;
&#xD;
          -  Participant previously enrolled in this study&#xD;
&#xD;
          -  Cervix diameter smaller than 26 mm&#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>HUG - Department Women, Child &amp; Adolescent</name>
      <address>
        <city>Geneva</city>
        <state>Vaud</state>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <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>February 2022</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>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04441281
org study id: Aspivix_IUD2019_Comparative
nct id: NCT04441281
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 comparative study is to assess the patient's pain and bleeding using the
      AspivixTM device in comparison with a commonly used single-tooth tenaculum (Pozzi forceps).
      Additionally, the comparative study aims to assess and compare the safety of the AspivixTM
      device with the single-tooth tenaculum (Pozzi forceps).

      Note: Study is made of 2 phases (pilot phase followed by a comparative phase). Details
      regarding pilot study is registered separately.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
masking description: Single-blinded - Participants will be blinded towards the intervention used. Additionally, the type of device used will only be revealed to the practitioner after randomization, immediately prior IUD insertion.
measure: Patient-reported pain: Visual Analogic Scale
time frame: Before the procedure
description: Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.
measure: Patient-reported pain: Visual Analogic Scale
time frame: During speculum insertion
description: Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.
measure: Patient-reported pain: Visual Analogic Scale
time frame: During AspivixTM / standard tenaculum application
description: Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.
measure: Patient-reported pain: Visual Analogic Scale
time frame: During application of cervical traction
description: Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.
measure: Patient-reported pain: Visual Analogic Scale
time frame: During IUD insertion
description: Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.
measure: Patient-reported pain: Visual Analogic Scale
time frame: During AspivixTM / standard tenaculum release
description: Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.
measure: Patient-reported pain: Visual Analogic Scale
time frame: 5 minutes after the end of the procedure
description: Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.
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: number of placement attempts before traction can be applied The number of placement attempts before traction of the cervix can be applied will be recorded
measure: The number of spontaneous releases
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 the efficacy of the investigational device and its comparator by the practitioner
time frame: During the procedure to insert the IUD which should last less than 5 minutes.
description: 5 point Likert 'Efficacy Questionnaire' will be used. Minimal to maximal values range from 1 to 5, 1 meaning "disagree" and 5 "agree".
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)
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: Single-tooth tenaculum (Pozzi forceps)
arm group type: Active Comparator
description: In the control arm, a single-tooth tenaculum, Pozzi forceps, used during routine IUD insertion, is employed to hold and stabilize the cervix.
arm group label: AspivixTM cervical vacuum tenaculum
arm group type: Experimental
description: In the experimental arm, the investigational AspivixTM cervical vacuum tenaculum is employed to hold and stabilize the cervix.
intervention type: Procedure
intervention name: Traction of the cervix for IUD insertion
description: Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD).
arm group label: AspivixTM cervical vacuum tenaculum
arm group label: Single-tooth tenaculum (Pozzi forceps)
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: 
facility: 
country: Switzerland
responsible party type: Sponsor