<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/NCT03281460</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL16_0714</org_study_id>
    <secondary_id>2017-A01773-50</secondary_id>
    <nct_id>NCT03281460</nct_id>
  </id_info>
  <brief_title>Efficacy of In-bag Morcellation</brief_title>
  <acronym>FIBROSAC</acronym>
  <official_title>Efficacy of In-bag Morcellation</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>
      Laparoscopic mini-invasive surgery supplanted laparotomy for many years, including&#xD;
      hysterectomy or myomectomy (less postoperative complications compared to laparotomy) However&#xD;
      the US Federal Drug Administration (FDA) strongly warned against the use of power&#xD;
      morcellation in 2014 because of the risk of iatrogenic spread of malignant cells.&#xD;
&#xD;
      The hypothesis is that in-bag morcellation may prevent cells dissemination. The investigator&#xD;
      compare in this prospective randomized study two groups of patients: group A (in&#xD;
      bag-morcellation during laparoscopic myomectomy or hysterectomy) versus group B (morcellation&#xD;
      without any bag during laparoscopic myomectomy or hysterectomy)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2018</start_date>
  <completion_date type="Actual">January 21, 2019</completion_date>
  <primary_completion_date type="Actual">January 21, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smooth muscular cells in the peritoneal fluid after morcellation</measure>
    <time_frame>Day 0 - just after surgery</time_frame>
    <description>After morcellation, there will be cytology and immunohistochemistry of peritoneal washing with 500cc of saline serum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of surgery</measure>
    <time_frame>Day 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>morcellation time</measure>
    <time_frame>Day 0 - during surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>peritoneal washing time</measure>
    <time_frame>Day 0 - during surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>residual morcellated tissues weight</measure>
    <time_frame>Day 0 - during surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bag associated time</measure>
    <time_frame>Day 0 - during surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ease of use</measure>
    <time_frame>Day 0 - during surgery</time_frame>
    <description>assessment by a visual analogical scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Uterine Myomatosis</condition>
  <condition>Laparoscopy</condition>
  <condition>Hysterectomy, Vaginal</condition>
  <arm_group>
    <arm_group_label>with in-bag morcellation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>with More-cell-Safe AMI bag morcellation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>without any morcellation bag</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>without any morcellation bag</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation</intervention_name>
    <description>laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation</description>
    <arm_group_label>with in-bag morcellation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic myomectomy or hysterectomy without any morcellation bag</intervention_name>
    <description>laparoscopic myomectomy or hysterectomy without any morcellation bag</description>
    <arm_group_label>without any morcellation bag</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18 years or more&#xD;
&#xD;
          -  Laparoscopic myomectomy or laparoscopic subtotal hysterectomy&#xD;
&#xD;
          -  Informed and signed consent&#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;
          -  Preoperative risk of leiomyosarcoma or pelvic carcinoma&#xD;
&#xD;
          -  Pregnancy or desire of pregnancy during the study period&#xD;
&#xD;
          -  Uterus or myomas weight above 1.000 g&#xD;
&#xD;
          -  Inability to understand information provided&#xD;
&#xD;
          -  Not covered by a national health insurance scheme, prisoner or under administrative&#xD;
             supervision&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gautier CHENE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gynaecology Department, Hôpital Femme Mère Enfant, HCL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gynaecology Department, Hôpital Femme Mère Enfant</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</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>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hysterectomy, Vaginal</keyword>
  <keyword>Uterine Myomatosis</keyword>
  <keyword>Morcellation</keyword>
  <keyword>Laparoscopy</keyword>
  <keyword>in-bag morcellation</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03281460
org study id: 69HCL16_0714
secondary id: 2017-A01773-50
nct id: NCT03281460
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Laparoscopic mini-invasive surgery supplanted laparotomy for many years, including
      hysterectomy or myomectomy (less postoperative complications compared to laparotomy) However
      the US Federal Drug Administration (FDA) strongly warned against the use of power
      morcellation in 2014 because of the risk of iatrogenic spread of malignant cells.

      The hypothesis is that in-bag morcellation may prevent cells dissemination. The investigator
      compare in this prospective randomized study two groups of patients: group A (in
      bag-morcellation during laparoscopic myomectomy or hysterectomy) versus group B (morcellation
      without any bag during laparoscopic myomectomy or hysterectomy)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Smooth muscular cells in the peritoneal fluid after morcellation
time frame: Day 0 - just after surgery
description: After morcellation, there will be cytology and immunohistochemistry of peritoneal washing with 500cc of saline serum
measure: duration of surgery
time frame: Day 0
measure: morcellation time
time frame: Day 0 - during surgery
measure: peritoneal washing time
time frame: Day 0 - during surgery
measure: residual morcellated tissues weight
time frame: Day 0 - during surgery
measure: bag associated time
time frame: Day 0 - during surgery
measure: ease of use
time frame: Day 0 - during surgery
description: assessment by a visual analogical scale
arm group label: with in-bag morcellation
arm group type: Experimental
description: with More-cell-Safe AMI bag morcellation
arm group label: without any morcellation bag
arm group type: Active Comparator
description: without any morcellation bag
intervention type: Device
intervention name: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
description: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
arm group label: with in-bag morcellation
intervention type: Procedure
intervention name: laparoscopic myomectomy or hysterectomy without any morcellation bag
description: laparoscopic myomectomy or hysterectomy without any morcellation bag
arm group label: without any morcellation bag
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gautier CHENE, MD
role: Principal Investigator
affiliation: Gynaecology Department, Hôpital Femme Mère Enfant, HCL
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided