<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/NCT04435496</url>
  </required_header>
  <id_info>
    <org_study_id>BC-07362</org_study_id>
    <nct_id>NCT04435496</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Learning Curve to Anchor GYN-CS® Device</brief_title>
  <acronym>GYN-CS-106</acronym>
  <official_title>Study to Evaluate the Learning Curve to Anchor a Frameless Copper-releasing Device (GYN-CS®) During Caesarean Section With a Follow-up of 3 Years Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</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>
      GYN-CS® is a new concept in intrauterine device technology. It is fixed to the uterine&#xD;
      fundus, is frameless and entirely flexible. The GYN-CS® 3 has a lifespan of 3 years and&#xD;
      GYN-CS® 10 has lifespan of 10 years, both used in this study. The primary objectives are:&#xD;
      Analyse the learning curve of the surgeon and the ease of insertion of the device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a mono-center, open-label, single-arm (non-randomized trial, in which each&#xD;
      participant receives GYN-CS® 3 or GYN-CS® 10) prospective study for the insertion evaluation&#xD;
      of GYN-CS®. Providing no complications occur, the women will remain in the study for 3 years.&#xD;
&#xD;
      The study will be conducted in 20 healthy women between 18 and 48 years scheduled for&#xD;
      elective Caesarean section.&#xD;
&#xD;
      The learning curve parameters are the time of the procedure (starts after removal of the&#xD;
      placenta when the uterus is completely empty and ends when the device is correctly inserted)&#xD;
      and a scale for the ease of insertion of the device.&#xD;
&#xD;
      Following insertion of GYN-CS® 3 and 10, women will be reexamined at discharge, at 6-8 weeks,&#xD;
      at 1, 2 and 3 years after insertion. At 3 years after insertion of the GYN-CS® 3, it will be&#xD;
      removed during the follow-up visit. At 3 years after insertion of the GYN-CS® 10, the device&#xD;
      doesn't need to be removed at the follow-up visit. During every visit a vaginal ultrasound&#xD;
      and gynecological examination are performed as well as a satisfactory scale of the IUD is&#xD;
      questioned at the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 5, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">May 31, 2023</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>The study will be conducted in 20 healthy women between 18 and 48 years scheduled for elective Caesarean section.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analyse the learning curve of the placement of the IUD by the surgeon</measure>
    <time_frame>During the placement of the IUD</time_frame>
    <description>procedure time: the time of the device placement starts after removal of the placenta when the uterus is completely empty and ends when the device is correctly inserted</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analyse the learning curve of the placement of the IUD by the surgeon</measure>
    <time_frame>During the placement of the IUD</time_frame>
    <description>successful insertion with adequate position during follow-up evaluations. The adequate position of the IUD will be checked by visualisation of the IUD by performing a vaginal ultrasound.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ease of insertion of the IUD</measure>
    <time_frame>During the placement of the IUD</time_frame>
    <description>The ease of insertion of the IUD will be measured, using the following scale:&#xD;
1. The insertion of the device went smoothly&#xD;
2. I had little trouble inserting the device, but experienced this as a not important delay in my surgical act&#xD;
3. The insertion of the device was rather difficult&#xD;
4. The insertion of the device was time consuming, difficult and dangerous&#xD;
5. The insertion of the device wasn't possible due to technical issues or medical reasons</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of insertion</measure>
    <time_frame>During the insertion of the device until the end of the procedure of IUD placement</time_frame>
    <description>All complications during the insertion of the IUD will be saved in a log</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expulsion rate and causes</measure>
    <time_frame>During the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up)</time_frame>
    <description>At every follow-up visit, expulsion of the IUD will be asked and the reason will be described in a log.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuation rate</measure>
    <time_frame>during the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up)</time_frame>
    <description>What is the reason for drop-out of the study?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction: Likert scale</measure>
    <time_frame>at every follow-up visit during the trial (4 days after the insertion of the IUD, 6-8 weeks after placement, 1 year after placement, 2 years after placement, 3 years after placement of the IUD)</time_frame>
    <description>Patient satisfaction by Likert scale at every follow up: very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. At removal, the ease of this action by the following scale for the physicians:&#xD;
1. I had little trouble with removing the device, but experienced this as a not important delay in my surgical act&#xD;
2. The removal of the device went smoothly&#xD;
3. The removal of the device was rather difficult&#xD;
4. The removal of the device was time consuming, difficult and dangerous&#xD;
5. The removal of the device wasn't possible due to technical issues or medical reasons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease if removal of the IUD</measure>
    <time_frame>at every follow-up visite (4 days after the insertion of the IUD, 6-8 weeks after placement, 1 year after placement, 2 years after placement, 3 years after placement of the IUD)</time_frame>
    <description>At removal, the ease of this action by the following scale for the physicians:&#xD;
1. I had little trouble with removing the device, but experienced this as a not important delay in my surgical act&#xD;
2. The removal of the device went smoothly&#xD;
3. The removal of the device was rather difficult&#xD;
4. The removal of the device was time consuming, difficult and dangerous&#xD;
5. The removal of the device wasn't possible due to technical issues or medical reasons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The pain of the patient during removal of the IUD: VAS scale</measure>
    <time_frame>3 years after insertion of the IUD</time_frame>
    <description>The pain will be measured using a VAS scale (1. no pain, 2. mild pain, 3. nasty pain, 4. severe pain, 5. unbearable pain)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Learning Curve</condition>
  <condition>Caesarean Section</condition>
  <condition>Intra-uterine Device</condition>
  <arm_group>
    <arm_group_label>GYN-CS insertion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>GYN-CS device will be inserted in women during their c-section. The study patient can chose between a lifespan of 3 years (GYN-CS 3) and a lifespan of 10 years (GYN-CS 10) of the device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GYN-CS</intervention_name>
    <description>placement of the GYN-CS device</description>
    <arm_group_label>GYN-CS insertion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Generally healthy, women,&#xD;
&#xD;
          -  Pregnant women in the second trimester&#xD;
&#xD;
          -  18-48 years of age&#xD;
&#xD;
          -  Birth by Caesarean section planned&#xD;
&#xD;
          -  Be willing to stay in the study for 3 years&#xD;
&#xD;
          -  Return for follow-up at the designated times&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The presence of infection of the uterus, clinical cervicitis or vaginitis (infection&#xD;
             should be ruled out)&#xD;
&#xD;
          -  Suspicion of endometrial or uterine pathology such as congenital malformation of the&#xD;
             uterus&#xD;
&#xD;
          -  Large uterine fibromata (&gt; 3 cm in diameter)&#xD;
&#xD;
          -  Acute leukemia&#xD;
&#xD;
          -  Severe blood clotting disorders and undiagnosed genital tract bleeding&#xD;
&#xD;
          -  Significant medical disease that in the medical opinion of the investigator is likely&#xD;
             to interfere with patient ability to complete the entire trial&#xD;
&#xD;
          -  Participants receiving corticosteroid therapy (hydrocortisone&gt;40mg/d or an equivalent)&#xD;
             or immunosuppressive drugs&#xD;
&#xD;
          -  Caesarean section &lt; 36 weeks&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristien Roelens, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Ghent</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eline Meireson, Msc</last_name>
    <phone>09/332 78 17</phone>
    <email>eline.meireson@uzgent.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eline Meireson</last_name>
      <phone>09/332 78 17</phone>
      <email>eline.meireson@uzgent.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</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/NCT04435496
org study id: BC-07362
nct id: NCT04435496
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
GYN-CS® is a new concept in intrauterine device technology. It is fixed to the uterine
      fundus, is frameless and entirely flexible. The GYN-CS® 3 has a lifespan of 3 years and
      GYN-CS® 10 has lifespan of 10 years, both used in this study. The primary objectives are:
      Analyse the learning curve of the surgeon and the ease of insertion of the device.
This study is a mono-center, open-label, single-arm (non-randomized trial, in which each
      participant receives GYN-CS® 3 or GYN-CS® 10) prospective study for the insertion evaluation
      of GYN-CS®. Providing no complications occur, the women will remain in the study for 3 years.

      The study will be conducted in 20 healthy women between 18 and 48 years scheduled for
      elective Caesarean section.

      The learning curve parameters are the time of the procedure (starts after removal of the
      placenta when the uterus is completely empty and ends when the device is correctly inserted)
      and a scale for the ease of insertion of the device.

      Following insertion of GYN-CS® 3 and 10, women will be reexamined at discharge, at 6-8 weeks,
      at 1, 2 and 3 years after insertion. At 3 years after insertion of the GYN-CS® 3, it will be
      removed during the follow-up visit. At 3 years after insertion of the GYN-CS® 10, the device
      doesn't need to be removed at the follow-up visit. During every visit a vaginal ultrasound
      and gynecological examination are performed as well as a satisfactory scale of the IUD is
      questioned at the patient.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The study will be conducted in 20 healthy women between 18 and 48 years scheduled for elective Caesarean section.
primary purpose: Other
masking: None (Open Label)
measure: Analyse the learning curve of the placement of the IUD by the surgeon
time frame: During the placement of the IUD
description: procedure time: the time of the device placement starts after removal of the placenta when the uterus is completely empty and ends when the device is correctly inserted
measure: Analyse the learning curve of the placement of the IUD by the surgeon
time frame: During the placement of the IUD
description: successful insertion with adequate position during follow-up evaluations. The adequate position of the IUD will be checked by visualisation of the IUD by performing a vaginal ultrasound.
measure: Ease of insertion of the IUD
time frame: During the placement of the IUD
description: The ease of insertion of the IUD will be measured, using the following scale:
1. The insertion of the device went smoothly
2. I had little trouble inserting the device, but experienced this as a not important delay in my surgical act
3. The insertion of the device was rather difficult
4. The insertion of the device was time consuming, difficult and dangerous
5. The insertion of the device wasn't possible due to technical issues or medical reasons
measure: Safety of insertion
time frame: During the insertion of the device until the end of the procedure of IUD placement
description: All complications during the insertion of the IUD will be saved in a log
measure: Expulsion rate and causes
time frame: During the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up)
description: At every follow-up visit, expulsion of the IUD will be asked and the reason will be described in a log.
measure: Continuation rate
time frame: during the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up)
description: What is the reason for drop-out of the study?
measure: Patient satisfaction: Likert scale
time frame: at every follow-up visit during the trial (4 days after the insertion of the IUD, 6-8 weeks after placement, 1 year after placement, 2 years after placement, 3 years after placement of the IUD)
description: Patient satisfaction by Likert scale at every follow up: very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. At removal, the ease of this action by the following scale for the physicians:
1. I had little trouble with removing the device, but experienced this as a not important delay in my surgical act
2. The removal of the device went smoothly
3. The removal of the device was rather difficult
4. The removal of the device was time consuming, difficult and dangerous
5. The removal of the device wasn't possible due to technical issues or medical reasons
measure: Ease if removal of the IUD
time frame: at every follow-up visite (4 days after the insertion of the IUD, 6-8 weeks after placement, 1 year after placement, 2 years after placement, 3 years after placement of the IUD)
description: At removal, the ease of this action by the following scale for the physicians:
1. I had little trouble with removing the device, but experienced this as a not important delay in my surgical act
2. The removal of the device went smoothly
3. The removal of the device was rather difficult
4. The removal of the device was time consuming, difficult and dangerous
5. The removal of the device wasn't possible due to technical issues or medical reasons
measure: The pain of the patient during removal of the IUD: VAS scale
time frame: 3 years after insertion of the IUD
description: The pain will be measured using a VAS scale (1. no pain, 2. mild pain, 3. nasty pain, 4. severe pain, 5. unbearable pain)
arm group label: GYN-CS insertion
arm group type: Other
description: GYN-CS device will be inserted in women during their c-section. The study patient can chose between a lifespan of 3 years (GYN-CS 3) and a lifespan of 10 years (GYN-CS 10) of the device.
intervention type: Device
intervention name: GYN-CS
description: placement of the GYN-CS device
arm group label: GYN-CS insertion
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 48 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kristien Roelens, MD
role: Principal Investigator
affiliation: University Hospital, Ghent
last name: Eline Meireson, Msc
phone: 09/332 78 17
email: eline.meireson@uzgent.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor
sharing ipd: No