<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/NCT03281564</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0479</org_study_id>
    <nct_id>NCT03281564</nct_id>
  </id_info>
  <brief_title>Quality of Life After Laparoscopic Removal of Essure®</brief_title>
  <acronym>ABLIMCO</acronym>
  <official_title>Prospective Study of Quality of Life After Laparoscopic Removal of Essure®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      A lot of patients seem to complain after hysteroscopic tubal occlusion by Essure® device with&#xD;
      a worce quality of life. Investigators' hypothesis is that Essure® laparoscopic removal may&#xD;
      improve quality of life. This prospectice study aim to assess the quality of life 1, 3, 6 and&#xD;
      12 months after Essure® removal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 14, 2017</start_date>
  <completion_date type="Anticipated">October 14, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 14, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life 1 month after laparoscopic removal of Essure®</measure>
    <time_frame>1 month</time_frame>
    <description>Questionnaire to assess the quality of life 1 month after laparoscopic removal of Essure® device</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Contraceptive Device; Complications</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Essure®</arm_group_label>
    <description>Patients with laparoscopic removal of Essure®</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality of life after Essure® removal</intervention_name>
    <description>Questionnaire to assess the quality of life 1, 3, 6 and 12 months after laparoscopic removal of Essure® device</description>
    <arm_group_label>Essure®</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with laparoscopic removal of Essure®&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women aged 18 years or more&#xD;
&#xD;
          -  patients with Essure® sterilization device&#xD;
&#xD;
          -  surgical removal of Essure® with bilateral salpingectomy by laparoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  interview revealing disorder entailing unacceptable risk of postoperative&#xD;
             complications: coagulation disorder, immune system disorder, evolutive disease, etc.&#xD;
&#xD;
          -  impaired lower-limb range of motion preventing positioning for surgery&#xD;
&#xD;
          -  inability to understand information provided&#xD;
&#xD;
          -  prisoner or under administrative supervision.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Gautier CHENE, MD</last_name>
    <phone>04 72 35 58 70</phone>
    <phone_ext>+33</phone_ext>
    <email>gautier.chene@chu-lyon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gautier CHENE, MD</last_name>
      <phone>04 72 35 58 70</phone>
      <phone_ext>+33</phone_ext>
      <email>gautier.chene@chu-lyon.fr</email>
    </contact>
    <investigator>
      <last_name>Gautier CHENE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 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/NCT03281564
org study id: 69HCL17_0479
nct id: NCT03281564
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A lot of patients seem to complain after hysteroscopic tubal occlusion by Essure® device with
      a worce quality of life. Investigators' hypothesis is that Essure® laparoscopic removal may
      improve quality of life. This prospectice study aim to assess the quality of life 1, 3, 6 and
      12 months after Essure® removal.
observational model: Case-Only
time perspective: Prospective
measure: Quality of life 1 month after laparoscopic removal of Essure®
time frame: 1 month
description: Questionnaire to assess the quality of life 1 month after laparoscopic removal of Essure® device
arm group label: Essure®
description: Patients with laparoscopic removal of Essure®
intervention type: Other
intervention name: Quality of life after Essure® removal
description: Questionnaire to assess the quality of life 1, 3, 6 and 12 months after laparoscopic removal of Essure® device
arm group label: Essure®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gautier CHENE, MD
phone: 04 72 35 58 70
phone ext: +33
email: gautier.chene@chu-lyon.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
sharing ipd: No