- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04404738
MicroPort® Endoscopic Instrument Control System to Accomplish Robotic-assisted Surgery in Urology (MARS)
August 30, 2020 updated by: Gao Xu, Changhai Hospital
Clinical Studies of Robotic-assisted Surgery in Urology With MicroPort® Endoscopic Instrument Control System
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xu Gao, professor
- Phone Number: 0086-021-31161718
- Email: gaoxu.changhai@foxmail.com
Study Locations
-
-
-
Shanghai, China
- Recruiting
- Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
-
Contact:
- Wei Xue, Professor
- Email: uroxuewei@163.com
-
Shanghai, China
- Recruiting
- The first affiliated hospital of naval medical university (Shanghai changhai hospital)
-
Contact:
- Xu Gao, Professor
- Phone Number: 86-021-31161718
- Email: gaoxu.changhai@foxmail.com
-
Shanghai, China
- Not yet recruiting
- Zhongshan Hospital Affiliated to Fudan University
-
Contact:
- Jianming Guo, Professor
- Email: guo.jianming@zs-hospital.sh.cn
-
Zhejiang, China
- Not yet recruiting
- Zhejiang Provincial People's Hospital
-
Contact:
- Dahong Zhang, master
- Email: Zhangdahong88@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- be aged between 18 years and 80 years;
- laparoscopic surgery is required with one of the following surgical indications:(1)planning to perform radical prostatectomy(clinical stage is T1 or T2,and PSA≥ 0.2ng/mL) ;(2) planning to perform nephrectomy
- being able to cooperate and complete the follow-up and related examinations;
- volunteer to participate in this study and sign the informed consent.
Exclusion Criteria:
- patients requiring emergency surgery;
- have severe cardiovascular or circulatory disease and cannot tolerate surgery;
- participated in other clinical trials in the last 3 months;
- failure to understand study requirements
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MicroPort® Surgical System
robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using MicroPort® surgical system
|
In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by Microport® Surgical System
|
Active Comparator: da Vinci Surgical System
robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using da Vinci surgical system
|
In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by da Vinci Surgical System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
surgical success rate
Time Frame: 24 hours following the surgery
|
Surgery is completed without conversion to other operations and without a re-operation caused by intraoperative complications within 24 hours
|
24 hours following the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood loss
Time Frame: during the surgery
|
Amount of intraoperative bleeding in the patient from the start to the end of the operation
|
during the surgery
|
operative time
Time Frame: during the surgery
|
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.
|
during the surgery
|
length of hospital stay
Time Frame: 24 hours after discharge
|
The total hospital days of subjects from the day of the operation to discharge.
|
24 hours after discharge
|
perioperative complication rate
Time Frame: 2 weeks after operation
|
The overall incidence of intraoperative and postoperative complications.
|
2 weeks after operation
|
The physiological load of the surgeon during the surgery
Time Frame: immediately after the surgery
|
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.
|
immediately after the surgery
|
The psychological load of the surgeon during the surgery
Time Frame: immediately after the surgery
|
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.
|
immediately after the surgery
|
the critical failure rate of the robotic system
Time Frame: during the surgery
|
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
|
during the surgery
|
the recoverable malfunction rate of the robotic system
Time Frame: during the surgery
|
Recoverable malfunction meant minor errors that could be easily resolved by the technician and has no significant impact on the process or the operation
|
during the surgery
|
Instrument performance
Time Frame: immediately after the surgery
|
The researcher fills in the instrument performance evaluation form after the operation to review the performance of the instrument during the test.
|
immediately after the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xu Gao, professor, Changhai Hospital
- Principal Investigator: Jianming Guo, professor, Shanghai Zhongshan Hospital
- Principal Investigator: Wei Xue, professor, Renji Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2020
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
May 18, 2020
First Submitted That Met QC Criteria
May 21, 2020
First Posted (Actual)
May 27, 2020
Study Record Updates
Last Update Posted (Actual)
September 1, 2020
Last Update Submitted That Met QC Criteria
August 30, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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