Robotic Surgical ProceduresMARSNCT04404738
MicroPort® Endoscopic Instrument Control System to Accomplish Robotic-assisted Surgery in Urology
A study testing MicroPort® robot-assisted laparoscopic surgery and da Vinci robot-assisted laparoscopic surgery in people with Robotic Surgical Procedures and Prostatectomy, run by Changhai Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Robotic Surgical Procedures, Prostatectomy, Nephrectomy
- What is being tested?
- MicroPort® robot-assisted laparoscopic surgery and da Vinci robot-assisted laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 4 sitesChina
- Study dates
- 29 Jun 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai
Wei Xue, Professor, uroxuewei@163.com
- Recruiting
The first affiliated hospital of naval medical university (Shanghai changhai hospital)
Shanghai
Xu Gao, Professor, 86-021-31161718, gaoxu.changhai@foxmail.com
- Not yet recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai
Jianming Guo, Professor, guo.jianming@zs-hospital.sh.cn
- Not yet recruiting
Zhejiang Provincial People's Hospital
Zhejiang
Dahong Zhang, master, Zhangdahong88@126.com
About this study
Official title: 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.
- Conditions
- Robotic Surgical Procedures, Prostatectomy, Nephrectomy
- Being tested
- MicroPort® robot-assisted laparoscopic surgery, da Vinci robot-assisted laparoscopic surgery
- Keywords
- robot, efficacy, safety, urology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroPort® robot-assisted laparoscopic surgeryProcedure or surgery
In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by Microport® Surgical System
da Vinci robot-assisted laparoscopic surgeryProcedure or surgery
In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by da Vinci Surgical System
| Study group | Role | What they receive |
|---|---|---|
| MicroPort® Surgical System | Experimental | robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using MicroPort® surgical system Receives: Procedure: MicroPort® robot-assisted laparoscopic surgery |
| da Vinci Surgical System | Active comparator | robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using da Vinci surgical system Receives: Procedure: da Vinci robot-assisted laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical success rate
Surgery is completed without conversion to other operations and without a re-operation caused by intraoperative complications within 24 hours
Measured: 24 hours following the surgery
Secondary outcomes (9)
blood loss
Amount of intraoperative bleeding in the patient from the start to the end of the operation
Measured: during the surgery
operative time
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.
Measured: during the surgery
length of hospital stay
The total hospital days of subjects from the day of the operation to discharge.
Measured: 24 hours after discharge
perioperative complication rate
The overall incidence of intraoperative and postoperative complications.
Measured: 2 weeks after operation
The physiological load of the surgeon during 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.
Measured: immediately after the surgery
The psychological load of the surgeon during 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.
Measured: immediately after the surgery
the critical failure rate of the robotic system
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
Measured: during the surgery
the recoverable malfunction rate of the robotic system
Recoverable malfunction meant minor errors that could be easily resolved by the technician and has no significant impact on the process or the operation
Measured: during the surgery
Instrument performance
The researcher fills in the instrument performance evaluation form after the operation to review the performance of the instrument during the test.
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start29 Jun 2020
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Xu, Changhai Hospital
- Investigators
- Xu Gao, professor, Principal investigator, Changhai HospitalJianming Guo, professor, Principal investigator, Shanghai Zhongshan HospitalWei Xue, professor, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404738
- Sponsor's protocol ID
- MPMB-2019-MKW
- Acronym
- MARS
- Status last verified
- Aug 2020
- First submitted
- 18 May 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Studies of Robotic-assisted Surgery in Urology With MicroPort® Endoscopic Instrument Control System
- ClinicalTrials.gov ID
- NCT04404738
- Acronym / sponsor ID
- MARS / MPMB-2019-MKW
- Conditions
- Robotic Surgical Procedures, Prostatectomy, Nephrectomy
- Keywords
- robot, efficacy, safety, urology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MicroPort® Surgical System | Experimental | Procedure: MicroPort® robot-assisted laparoscopic surgeryrobot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using MicroPort® surgical system |
| da Vinci Surgical System | Active comparator | Procedure: da Vinci robot-assisted laparoscopic surgeryrobot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using da Vinci surgical system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroPort® robot-assisted laparoscopic surgeryIn this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by Microport® Surgical System | Procedure or surgery | MicroPort® Surgical System |
| da Vinci robot-assisted laparoscopic surgeryIn this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by da Vinci Surgical System | Procedure or surgery | da Vinci Surgical System |
Primary outcome
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
9 secondary outcomes
blood loss
Time frame: during the surgery
operative time
Time frame: during the surgery
length of hospital stay
Time frame: 24 hours after discharge
perioperative complication rate
Time frame: 2 weeks after operation
The physiological load of the surgeon during the surgery
Time frame: immediately after the surgery
The psychological load of the surgeon during the surgery
Time frame: immediately after the surgery
the critical failure rate of the robotic system
Time frame: during the surgery
the recoverable malfunction rate of the robotic system
Time frame: during the surgery
Instrument performance
Time frame: immediately after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu Gao, professor principal investigator
Changhai Hospital
Jianming Guo, professor principal investigator
Shanghai Zhongshan Hospital
Wei Xue, professor principal investigator
RenJi Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MicroPort® robot-assisted laparoscopic surgery and da Vinci robot-assisted laparoscopic surgery in people with Robotic Surgical Procedures and Prostatectomy, run by Changhai Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Gao, professor (0086-021-31161718, gaoxu.changhai@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical success rate (time frame: 24 hours following the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.