MicroPort® Endoscopic Instrument Control System to Accomplish Robotic-assisted Surgery in Urology
MARS
Clinical Studies of Robotic-assisted Surgery in Urology With MicroPort® Endoscopic Instrument Control System
1 other identifier
interventional
104
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2020
CompletedFirst Posted
Study publicly available on registry
May 27, 2020
CompletedStudy Start
First participant enrolled
June 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedSeptember 1, 2020
August 1, 2020
2.2 years
May 18, 2020
August 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
surgical success rate
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 Outcomes (9)
blood loss
during the surgery
operative time
during the surgery
length of hospital stay
24 hours after discharge
perioperative complication rate
2 weeks after operation
The physiological load of the surgeon during the surgery
immediately after the surgery
- +4 more secondary outcomes
Study Arms (2)
MicroPort® Surgical System
EXPERIMENTALrobot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using MicroPort® surgical system
da Vinci Surgical System
ACTIVE COMPARATORrobot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using da Vinci surgical system
Interventions
In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by Microport® Surgical System
In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by da Vinci Surgical System
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
The first affiliated hospital of naval medical university (Shanghai changhai hospital)
Shanghai, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, China
Zhejiang Provincial People's Hospital
Zhejiang, China
Study Officials
- PRINCIPAL INVESTIGATOR
Xu Gao, professor
Changhai Hospital
- PRINCIPAL INVESTIGATOR
Jianming Guo, professor
Shanghai Zhongshan Hospital
- PRINCIPAL INVESTIGATOR
Wei Xue, professor
RenJi Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
May 18, 2020
First Posted
May 27, 2020
Study Start
June 29, 2020
Primary Completion
September 1, 2022
Study Completion
December 1, 2022
Last Updated
September 1, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share