MicroPort® Endoscopic Instrument Control System to Accomplish Robotic-assisted Surgery in Urology

NCT ID: NCT04404738

Last Updated: 2020-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-29

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Robotic Surgical Procedures Prostatectomy Nephrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MicroPort® Surgical System

robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using MicroPort® surgical system

Group Type EXPERIMENTAL

MicroPort® robot-assisted laparoscopic surgery

Intervention Type PROCEDURE

In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by Microport® Surgical System

da Vinci Surgical System

robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using da Vinci surgical system

Group Type ACTIVE_COMPARATOR

da Vinci robot-assisted laparoscopic surgery

Intervention Type PROCEDURE

In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by da Vinci Surgical System

Interventions

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MicroPort® robot-assisted laparoscopic surgery

In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by Microport® Surgical System

Intervention Type PROCEDURE

da Vinci robot-assisted laparoscopic surgery

In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by da Vinci Surgical System

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gao Xu

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xu Gao, professor

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Jianming Guo, professor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Wei Xue, professor

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

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Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status RECRUITING

The first affiliated hospital of naval medical university (Shanghai changhai hospital)

Shanghai, , China

Site Status RECRUITING

Zhongshan Hospital Affiliated to Fudan University

Shanghai, , China

Site Status NOT_YET_RECRUITING

Zhejiang Provincial People's Hospital

Zhejiang, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Xu Gao, professor

Role: CONTACT

0086-021-31161718

Facility Contacts

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Wei Xue, Professor

Role: primary

Xu Gao, Professor

Role: primary

86-021-31161718

Jianming Guo, Professor

Role: primary

Dahong Zhang, master

Role: primary

Other Identifiers

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MPMB-2019-MKW

Identifier Type: -

Identifier Source: org_study_id

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