Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000).

Sun Yat-sen University

Status: Unknown

Conditions: Urologic Neoplasms

Treatments: Device: endoscopic surgical instrument control system (SP1000: single-port laparoscopy); Device: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)

Study type: Interventional

Funder types: Other

Identifiers

NCT05025930

SysMU-Robot

Details and patient eligibility

About

Robot-assisted surgery has been successfully adopted rapidly over the last decade. Robotic technology with tridimensional imaging can improve operating dexterity, visualization of difficult anatomic locations. This is a prospective study aims to evaluate the safety and effectiveness of the domestic surgical robot.

Full description

In this clinical trial, the subjects will be randomly divided into two groups, and the urological typical surgical procedures (prostatectomy, and partial or radical nephrectomy) will be performed with the endoscopic surgical instrument control system SP1000 and IS3000.And the non-inferiorly comparison will be made between the surgical results of two systems to verify the safety and effectiveness of the endoscopic surgical instrument control system (SP1000).

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Any male or female age from 18 to 80
2. BMI 18-30kg/m2
3. Have urological surgery indications (cystectomy, prostatectomy, and nephrectomy)
4. Patients with physiologic conditions capable of receiving laparoscopic surgery
5. Be able to cooperate and complete the follow-up and related examinations
6. Volunteer to participate in this study and sign the informed consen

Exclusion criteria

1. The researchers assess patients with severe cardiovascular or circulatory disease and cannot tolerate the surgery
2. History of epilepsy or mental illness
3. Pregnant and lactation
4. Surgery history at the relevant surgical site, which is considered to influence surgical procedures
5. Severe allergic or addiction of drug and alcohol
6. Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastasis disease
7. Inability to understand the trial or complete the follow-up
8. Participated in other therapeutic clinical trials within 90 days
9. Patients who had undergone major operation and major trauma within 28 days prior to enrollment, which the researchers considered to have an impact on the outcome of surgery
10. Patients deemed unsuitable to participate in this trial by researchers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

endoscopic surgical instrument control system (SP1000: single- port laparoscopy)

Experimental group

Description:

Urological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (SP1000)

Treatment:

Device: endoscopic surgical instrument control system (SP1000: single-port laparoscopy)

Comparator: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)

Active Comparator group

Description:

Urological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (IS3000)

Treatment:

Device: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)