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

Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000): a Multi-center, Randomized, Single-blind, Parallel Controlled Clinical Tria

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urologic Neoplasms
• Intervention / Treatment: Device: endoscopic surgical instrument control system (SP1000: single-port laparoscopy); Device: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)

Detailed 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).

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaiwen Li, MD; Phone Number: +86-02034078960; Email: likw6@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: endoscopic surgical instrument control system (SP1000: single- port laparoscopy); Urological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (SP1000)	Device: endoscopic surgical instrument control system (SP1000: single-port laparoscopy); The system will be used in conjunction with other equipment during endoscopic surgery to accurately control endoscopic surgical instruments and perform delicate surgical procedures such as grasping, cutting, blunt separation, hemostasis, ligation and suture.
Active Comparator: Comparator: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy); Urological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (IS3000)	Device: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy); The system will be used in conjunction with other equipment during endoscopic surgery to accurately control endoscopic surgical instruments and perform delicate surgical procedures such as grasping, cutting, blunt separation, hemostasis, ligation and suture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical success rate	The surgical success rate was defined as the percentage of patients in the experimental group and the control group who were successfully operated with the systems	24 hours
Incidence of serious adverse events during clinical trial		3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative complication rate	Perioperative complication will be graded using the Clavien-Dindo Complication Classification. The proportion and severity of perioperative complications will be analyzed	3 months
Changes in serum creatinine	Evaluating renal function by changes in serum creatinine after surgery for partial or radical nephrectomy	3 months
Changes in prostate-specific antigen levels	Changes in prostate-specific antigen levels will be measured after surgery for patients who undergone radical prostatectomy	3 months
Tumor recurrence rate		3 months
Machine installation time	Time from sheeting to complete the installation of surgical instruments	preoperative
Operative time		12 hours
Blood loss during the surgery		12 hours
Margin positive rate		1 month
Pain after surgery	Visual analogue scale as a monitoring tool for postoperative pain	24 hours
Surgeon Satisfaction	NASA-TLX quantification table will be used to evaluate surgeon satisfaction after surgery	12 hours

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Collaborators: The First Affiliated Hospital of Nanchang University; Chinese PLA General Hospital; Edge Medical Robotics CO.,LTD
• Investigators: Principal Investigator: Tianxin Lin, MD, Sun Yat-sen Memorial Hospital，Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 29, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Neoplasms
• Other Study ID Numbers: SysMU-Robot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No