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

Naval Military Medical University

Status: Unknown

Conditions: Prostatectomy; Nephrectomy; Robotic Surgical Procedures

Treatments: Procedure: MicroPort® robot-assisted laparoscopic surgery; Procedure: da Vinci robot-assisted laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04404738

MPMB-2019-MKW

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

MicroPort® Surgical System

Experimental group

Description:

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

Treatment:

Procedure: MicroPort® robot-assisted laparoscopic surgery

da Vinci Surgical System

Active Comparator group

Description:

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

Treatment:

Procedure: da Vinci robot-assisted laparoscopic surgery