<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/NCT04406597</url>
  </required_header>
  <id_info>
    <org_study_id>NTCS-LOC</org_study_id>
    <nct_id>NCT04406597</nct_id>
  </id_info>
  <brief_title>Safety, Effectiveness and Operability of Using the New Tissue Containment System During Laparoscopic Ovarian Cystectomy</brief_title>
  <official_title>Safety, Effectiveness and Operability of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laparoscopic Ovarian Cystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China-Japan Friendship Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to evaluate the safety, effectiveness and operability of performing&#xD;
      in-bag cystectomy and morcellation with the new tissue containment system during laparoscopic&#xD;
      ovarian cystectomy. Premenopausal women, aged 18-45 undergoing laparoscopic cystectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 20, 2022</start_date>
  <completion_date type="Anticipated">December 10, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 10, 2023</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The exposure rate</measure>
    <time_frame>End of study - approximately two years</time_frame>
    <description>• Exposure is defined as &quot;disruption of the device (using dye leak testing or water testing) or visible tissue dissemination&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The ovarian reserve function</measure>
    <time_frame>Three months after the surgery</time_frame>
    <description>The ovarian reserve function is reflected by the concentration of anti-mullerian hormone(AMH)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean procedure time</measure>
    <time_frame>Within one week after the surgery</time_frame>
    <description>Mean procedure time will be measured by hour/minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss during operation</measure>
    <time_frame>Within one week after the surgery</time_frame>
    <description>Blood loss during operation will be measured by volume (mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Intra- or post-operative complications</measure>
    <time_frame>Three months after the surgery</time_frame>
    <description>Intra or post complications rate (e.g. urinary, intestinal or nerve injury)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The patients' life quality postoperative: questionaire</measure>
    <time_frame>Three months after the surgery</time_frame>
    <description>The patients' life quality will be measured by The World Health Organization's Quality of Life Questionnaire-Brief Version（WHOQOL-BREF).The maximum value is 120 and the minimum is 0. The higher score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Surgery Task Load Index</measure>
    <time_frame>Within one week after the surgery</time_frame>
    <description>The Surgery Task Load Index will be measured by questionaire. The maximum value is 120 and the minimum is 0. The higher score means a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of failure during in-bag cystectomy procedure</measure>
    <time_frame>End of study - approximately two years</time_frame>
    <description>Failure is defined as the operator's inability to successfully insert and extract the device.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Ovary Neoplasm</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>the New Tissue Containment System group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Without any protection system during Laparoscopic Ovarian Cystectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>the New Tissue Containment System</intervention_name>
    <description>Laparoscopic Ovarian Cystectomy using the New Tissue Containment System</description>
    <arm_group_label>the New Tissue Containment System group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premenopausal woman patient age 18-45 years&#xD;
&#xD;
          -  Women with regular period&#xD;
&#xD;
          -  Women with ovarian neoplasm (size: 3-10cm)&#xD;
&#xD;
          -  Laparoscopic surgery required&#xD;
&#xD;
          -  Body mass index 18.5-27.9kg/m2&#xD;
&#xD;
          -  Subject able to comprehend and give informed consent for participation in this study&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is not considered suitable for a laparoscopic ovarian cystectomy procedure&#xD;
&#xD;
          -  The ovaries and pelvic cavity are severely adhered, and the tumor ruptures when free&#xD;
&#xD;
          -  Women with Polycystic ovary syndrome&#xD;
&#xD;
          -  Baseline AMH less than 0.5ng / mL&#xD;
&#xD;
          -  Known to have participated in any other clinical trials or hormone therapy within 3&#xD;
             months&#xD;
&#xD;
          -  Women during pregnancy and lactation&#xD;
&#xD;
          -  Women in acute stage infection of reproductive system or other parts&#xD;
&#xD;
          -  Women combined with severe central nervous system, cardiovascular system, liver and&#xD;
             kidney, digestive tract, respiratory system, endocrine metabolism (thyroid disease,&#xD;
             Cushing syndrome, hyperprolactinemia) and skeletal muscle system and mental disorders&#xD;
             contraindicating laparoscopic surgery&#xD;
&#xD;
          -  Women with known or suspected poor compliance who cannot complete the trial&#xD;
&#xD;
          -  Those who can not sign the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yao Wang, MD</last_name>
    <phone>8684206115</phone>
    <email>wangyaopumc@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>China-Japan Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>086010</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>fang zhao</last_name>
      <phone>08601084206115</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China-Japan Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Jing Liang</investigator_full_name>
    <investigator_title>Vice Director of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04406597
org study id: NTCS-LOC
nct id: NCT04406597
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study is designed to evaluate the safety, effectiveness and operability of performing
      in-bag cystectomy and morcellation with the new tissue containment system during laparoscopic
      ovarian cystectomy. Premenopausal women, aged 18-45 undergoing laparoscopic cystectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The exposure rate
time frame: End of study - approximately two years
description: • Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".
measure: The ovarian reserve function
time frame: Three months after the surgery
description: The ovarian reserve function is reflected by the concentration of anti-mullerian hormone(AMH)
measure: Mean procedure time
time frame: Within one week after the surgery
description: Mean procedure time will be measured by hour/minutes.
measure: Estimated blood loss during operation
time frame: Within one week after the surgery
description: Blood loss during operation will be measured by volume (mL)
measure: Rate of Intra- or post-operative complications
time frame: Three months after the surgery
description: Intra or post complications rate (e.g. urinary, intestinal or nerve injury)
measure: The patients' life quality postoperative: questionaire
time frame: Three months after the surgery
description: The patients' life quality will be measured by The World Health Organization's Quality of Life Questionnaire-Brief Version（WHOQOL-BREF).The maximum value is 120 and the minimum is 0. The higher score means a better outcome.
measure: The Surgery Task Load Index
time frame: Within one week after the surgery
description: The Surgery Task Load Index will be measured by questionaire. The maximum value is 120 and the minimum is 0. The higher score means a worse outcome.
measure: The rate of failure during in-bag cystectomy procedure
time frame: End of study - approximately two years
description: Failure is defined as the operator's inability to successfully insert and extract the device.
arm group label: the New Tissue Containment System group
arm group type: Experimental
description: Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy
arm group label: Open group
arm group type: No Intervention
description: Without any protection system during Laparoscopic Ovarian Cystectomy
intervention type: Device
intervention name: the New Tissue Containment System
description: Laparoscopic Ovarian Cystectomy using the New Tissue Containment System
arm group label: the New Tissue Containment System group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Yao Wang, MD
phone: 8684206115
email: wangyaopumc@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China-Japan Friendship Hospital
investigator full name: Jing Liang
investigator title: Vice Director of Obstetrics and Gynecology
mesh term: Ovarian Neoplasms