<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/NCT04404738</url>
  </required_header>
  <id_info>
    <org_study_id>MPMB-2019-MKW</org_study_id>
    <nct_id>NCT04404738</nct_id>
  </id_info>
  <brief_title>MicroPort® Endoscopic Instrument Control System to Accomplish Robotic-assisted Surgery in Urology</brief_title>
  <acronym>MARS</acronym>
  <official_title>Clinical Studies of Robotic-assisted Surgery in Urology With MicroPort® Endoscopic Instrument Control System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhai 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>
      Laparoscopy, now virtually completely, was replaced with robotic surgery in uro-oncological&#xD;
      surgery in the world. And given the significant increase in the number of robotic surgeries&#xD;
      for prostate, bladder and kidney cancer, it is now a major domain in oncological surgery.&#xD;
      Microport MedBot Inc. has independently developed a domestic surgical robot in China.&#xD;
      Therefore, the purpose of the study is to evaluate the safety and efficacy of the Chinese&#xD;
      robot when applied to surgery in oncology.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2022</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>surgical success rate</measure>
    <time_frame>24 hours following the surgery</time_frame>
    <description>Surgery is completed without conversion to other operations and without a re-operation caused by intraoperative complications within 24 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood loss</measure>
    <time_frame>during the surgery</time_frame>
    <description>Amount of intraoperative bleeding in the patient from the start to the end of the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operative time</measure>
    <time_frame>during the surgery</time_frame>
    <description>The starting point and end point of the operation time are the first effective movement of the robot arm and the movement stop of the robot arm after the operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>24 hours after discharge</time_frame>
    <description>The total hospital days of subjects from the day of the operation to discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>perioperative complication rate</measure>
    <time_frame>2 weeks after operation</time_frame>
    <description>The overall incidence of intraoperative and postoperative complications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The physiological load of the surgeon during the surgery</measure>
    <time_frame>immediately after the surgery</time_frame>
    <description>The physiological load is assessed by the LED scale immediately after the surgery. LED is the local experienced discomfort scale used to assess the intraoperative physiological load of different parts of the surgeon's body. There are 10 points in the scale, and higher score means worse, with 0 means no discomfort and 10 is the worst discomfort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The psychological load of the surgeon during the surgery</measure>
    <time_frame>immediately after the surgery</time_frame>
    <description>The psychological load is assessed by the SME scale immediately after the operation. SME scale is the subjective mental effort scale used to assess the intraoperative psychological load of the surgeon. The scale has a total of 150 points, with a scale of 10 points. The higher the score, the worse it is, with 0 means no any difficult and above 110 points means extremely difficult.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the critical failure rate of the robotic system</measure>
    <time_frame>during the surgery</time_frame>
    <description>Critical failures that are difficult to repair in a short period of time during robot-assisted surgery and can have a serious impact on the process or the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the recoverable malfunction rate of the robotic system</measure>
    <time_frame>during the surgery</time_frame>
    <description>Recoverable malfunction meant minor errors that could be easily resolved by the technician and has no significant impact on the process or the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Instrument performance</measure>
    <time_frame>immediately after the surgery</time_frame>
    <description>The researcher fills in the instrument performance evaluation form after the operation to review the performance of the instrument during the test.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Robotic Surgical Procedures</condition>
  <condition>Prostatectomy</condition>
  <condition>Nephrectomy</condition>
  <arm_group>
    <arm_group_label>MicroPort® Surgical System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using MicroPort® surgical system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>da Vinci Surgical System</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using da Vinci surgical system</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MicroPort® robot-assisted laparoscopic surgery</intervention_name>
    <description>In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by Microport® Surgical System</description>
    <arm_group_label>MicroPort® Surgical System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>da Vinci robot-assisted laparoscopic surgery</intervention_name>
    <description>In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by da Vinci Surgical System</description>
    <arm_group_label>da Vinci Surgical System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be aged between 18 years and 80 years;&#xD;
&#xD;
          -  laparoscopic surgery is required with one of the following surgical&#xD;
             indications:(1)planning to perform radical prostatectomy(clinical stage is T1 or&#xD;
             T2,and PSA≥ 0.2ng/mL) ;(2) planning to perform nephrectomy&#xD;
&#xD;
          -  being able to cooperate and complete the follow-up and related examinations;&#xD;
&#xD;
          -  volunteer to participate in this study and sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients requiring emergency surgery;&#xD;
&#xD;
          -  have severe cardiovascular or circulatory disease and cannot tolerate surgery;&#xD;
&#xD;
          -  participated in other clinical trials in the last 3 months;&#xD;
&#xD;
          -  failure to understand study requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xu Gao, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhai Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jianming Guo, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Zhongshan Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wei Xue, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>RenJi Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xu Gao, professor</last_name>
    <phone>0086-021-31161718</phone>
    <email>gaoxu.changhai@foxmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Xue, Professor</last_name>
      <email>uroxuewei@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of naval medical university (Shanghai changhai hospital)</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xu Gao, Professor</last_name>
      <phone>86-021-31161718</phone>
      <email>gaoxu.changhai@foxmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Affiliated to Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jianming Guo, Professor</last_name>
      <email>guo.jianming@zs-hospital.sh.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhejiang Provincial People's Hospital</name>
      <address>
        <city>Zhejiang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dahong Zhang, master</last_name>
      <email>Zhangdahong88@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>August 30, 2020</last_update_submitted>
  <last_update_submitted_qc>August 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>Gao Xu</investigator_full_name>
    <investigator_title>Chief Physician</investigator_title>
  </responsible_party>
  <keyword>robot</keyword>
  <keyword>efficacy</keyword>
  <keyword>safety</keyword>
  <keyword>urology</keyword>
  <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/NCT04404738
org study id: MPMB-2019-MKW
nct id: NCT04404738
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Laparoscopy, now virtually completely, was replaced with robotic surgery in uro-oncological
      surgery in the world. And given the significant increase in the number of robotic surgeries
      for prostate, bladder and kidney cancer, it is now a major domain in oncological surgery.
      Microport MedBot Inc. has independently developed a domestic surgical robot in China.
      Therefore, the purpose of the study is to evaluate the safety and efficacy of the Chinese
      robot when applied to surgery in oncology.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: surgical success rate
time frame: 24 hours following the surgery
description: Surgery is completed without conversion to other operations and without a re-operation caused by intraoperative complications within 24 hours
measure: blood loss
time frame: during the surgery
description: Amount of intraoperative bleeding in the patient from the start to the end of the operation
measure: operative time
time frame: during the surgery
description: The starting point and end point of the operation time are the first effective movement of the robot arm and the movement stop of the robot arm after the operation.
measure: length of hospital stay
time frame: 24 hours after discharge
description: The total hospital days of subjects from the day of the operation to discharge.
measure: perioperative complication rate
time frame: 2 weeks after operation
description: The overall incidence of intraoperative and postoperative complications.
measure: The physiological load of the surgeon during the surgery
time frame: immediately after the surgery
description: The physiological load is assessed by the LED scale immediately after the surgery. LED is the local experienced discomfort scale used to assess the intraoperative physiological load of different parts of the surgeon's body. There are 10 points in the scale, and higher score means worse, with 0 means no discomfort and 10 is the worst discomfort.
measure: The psychological load of the surgeon during the surgery
time frame: immediately after the surgery
description: The psychological load is assessed by the SME scale immediately after the operation. SME scale is the subjective mental effort scale used to assess the intraoperative psychological load of the surgeon. The scale has a total of 150 points, with a scale of 10 points. The higher the score, the worse it is, with 0 means no any difficult and above 110 points means extremely difficult.
measure: the critical failure rate of the robotic system
time frame: during the surgery
description: Critical failures that are difficult to repair in a short period of time during robot-assisted surgery and can have a serious impact on the process or the operation
measure: the recoverable malfunction rate of the robotic system
time frame: during the surgery
description: Recoverable malfunction meant minor errors that could be easily resolved by the technician and has no significant impact on the process or the operation
measure: Instrument performance
time frame: immediately after the surgery
description: The researcher fills in the instrument performance evaluation form after the operation to review the performance of the instrument during the test.
arm group label: MicroPort® Surgical System
arm group type: Experimental
description: robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using MicroPort® surgical system
arm group label: da Vinci Surgical System
arm group type: Active Comparator
description: robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using da Vinci surgical system
intervention type: Procedure
intervention name: MicroPort® robot-assisted laparoscopic surgery
description: In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by Microport® Surgical System
arm group label: MicroPort® Surgical System
intervention type: Procedure
intervention name: da Vinci robot-assisted laparoscopic surgery
description: In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by da Vinci Surgical System
arm group label: da Vinci Surgical System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xu Gao, professor
role: Principal Investigator
affiliation: Changhai Hospital
last name: Jianming Guo, professor
role: Principal Investigator
affiliation: Shanghai Zhongshan Hospital
last name: Wei Xue, professor
role: Principal Investigator
affiliation: RenJi Hospital
last name: Xu Gao, professor
phone: 0086-021-31161718
email: gaoxu.changhai@foxmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Changhai Hospital
investigator full name: Gao Xu
investigator title: Chief Physician
sharing ipd: No