<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/NCT04423172</url>
  </required_header>
  <id_info>
    <org_study_id>NTCS-LH</org_study_id>
    <nct_id>NCT04423172</nct_id>
  </id_info>
  <brief_title>Safety, Efficacy and Operability of Using the New Tissue Containment System During Laprascopic Hysterectomy</brief_title>
  <official_title>Safety, Efficacy and Operability of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laprascopic Hysterectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jing Liang</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, operability and efficacy of performing the new&#xD;
      tissue containment system during laparoscopic hysterectomy. Pre- and perimenopausal women&#xD;
      undergoing laparoscopic hysterectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 16, 2020</start_date>
  <completion_date type="Anticipated">December 26, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 16, 2021</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The exposure rate</measure>
    <time_frame>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>Mean procedure time</measure>
    <time_frame>Within one day after the surgery</time_frame>
    <description>Mean procedure time will be measured by hour/minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The probability of failure during in-bag morcellation procedure</measure>
    <time_frame>approximately two years</time_frame>
    <description>Failure is defined as the operator's inability to successfully insert and extract the device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss during operation</measure>
    <time_frame>Within one day after the surgery</time_frame>
    <description>Blood loss during operation will be measured by volume (mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative pain</measure>
    <time_frame>Within one month after the surgery</time_frame>
    <description>The patients' post-operative pain will be measured by The Visual Analog Score （VAS).The maximum value is 10 and the minimum is 0. The lower score means a better outcome.</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 Surgeon 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 Patients' life quality postoperative</measure>
    <time_frame>One 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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Gynecologic Surgery</condition>
  <arm_group>
    <arm_group_label>Using 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 Hysterectomy. The divice is a soft specimen bag in which the uterus tissue is sealed and quickly morcellation and removed through vagina. The divice is named the new tissue containment system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Without using any procteciton system during Laprascopic Hysterectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>the new tissue containment system</intervention_name>
    <description>Using the new tissue containment system during Laparoscopic hysterectomy. The divice is a soft specimen bag in which the uterus tissue is sealed and quickly morcellation and removed through vagina. The divice is named the new tissue containment system.</description>
    <arm_group_label>Using the New Tissue Containment System group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pre- and Peri-menopausal woman patient age 18-65 years&#xD;
&#xD;
          -  Women with fibroids, adenomyosis, and endometrial hyperplasia and indication for&#xD;
             laparoscopic hysterectomy.&#xD;
&#xD;
          -  Normal Pap smear result within one year&#xD;
&#xD;
          -  The uterus is larger than 12 weeks of gestation&#xD;
&#xD;
          -  The body mass index of the patients is 18.5-27.9kg/m2&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with Known or suspected malignancy&#xD;
&#xD;
          -  patients during pregnancy and lactation&#xD;
&#xD;
          -  Known blood diseases, bleeding coagulation disease, any part of the active bleeding or&#xD;
             bleeding tendency of the constitution of the patient&#xD;
&#xD;
          -  Patients with known severe liver and kidney dysfunction;Liver function (ALT, AST) ≥ 2&#xD;
             times of normal upper limit, or renal function (Cr) ≥ normal upper limit&#xD;
&#xD;
          -  Patients who are known to have participated in any other clinical trial within 3&#xD;
             months&#xD;
&#xD;
          -  Patients who cannot sign informed consent&#xD;
&#xD;
          -  Patients with acute stage infection of the reproductive system or other sites&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jun Yang, MD</last_name>
    <phone>8684206115</phone>
    <email>kong-yj@163.com</email>
  </overall_contact>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>China-Japan Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Jing Liang</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>morcellation</keyword>
  <keyword>laparoscopic surgery</keyword>
  <keyword>hysterectomy</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>IPD will to be shared with other researchers after four years</ipd_description>
  </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/NCT04423172
org study id: NTCS-LH
nct id: NCT04423172
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study is designed to evaluate the safety, operability and efficacy of performing the new
      tissue containment system during laparoscopic hysterectomy. Pre- and perimenopausal women
      undergoing laparoscopic hysterectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The exposure rate
time frame: approximately two years
description: Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".
measure: Mean procedure time
time frame: Within one day after the surgery
description: Mean procedure time will be measured by hour/minutes.
measure: The probability of failure during in-bag morcellation procedure
time frame: approximately two years
description: Failure is defined as the operator's inability to successfully insert and extract the device.
measure: Estimated blood loss during operation
time frame: Within one day after the surgery
description: Blood loss during operation will be measured by volume (mL)
measure: Post-operative pain
time frame: Within one month after the surgery
description: The patients' post-operative pain will be measured by The Visual Analog Score （VAS).The maximum value is 10 and the minimum is 0. The lower score means a better outcome.
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 Surgeon 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 Patients' life quality postoperative
time frame: One 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.
arm group label: Using the New Tissue Containment System group
arm group type: Experimental
description: using the new tissue containment system during Laparoscopic Hysterectomy. The divice is a soft specimen bag in which the uterus tissue is sealed and quickly morcellation and removed through vagina. The divice is named the new tissue containment system.
arm group label: Open group
arm group type: No Intervention
description: Without using any procteciton system during Laprascopic Hysterectomy.
intervention type: Device
intervention name: the new tissue containment system
description: Using the new tissue containment system during Laparoscopic hysterectomy. The divice is a soft specimen bag in which the uterus tissue is sealed and quickly morcellation and removed through vagina. The divice is named the new tissue containment system.
arm group label: Using the New Tissue Containment System group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jun Yang, MD
phone: 8684206115
email: kong-yj@163.com
responsible party type: Sponsor-Investigator
investigator affiliation: China-Japan Friendship Hospital
investigator full name: Jing Liang
investigator title: professor
sharing ipd: Undecided
ipd description: IPD will to be shared with other researchers after four years