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

Urologic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05025930
• Other study ID #: SysMU-Robot
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2021
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Kaiwen Li, MD
• Phone: +86-02034078960
• Email: likw6[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Urologic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Chinese PLA General Hospital, Edge Medical Robotics CO.,LTD, The First Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of serious adverse events during clinical trial		3 months
Secondary	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
Secondary	Changes in serum creatinine	Evaluating renal function by changes in serum creatinine after surgery for partial or radical nephrectomy	3 months
Secondary	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
Secondary	Tumor recurrence rate		3 months
Secondary	Machine installation time	Time from sheeting to complete the installation of surgical instruments	preoperative
Secondary	Operative time		12 hours
Secondary	Blood loss during the surgery		12 hours
Secondary	Margin positive rate		1 month
Secondary	Pain after surgery	Visual analogue scale as a monitoring tool for postoperative pain	24 hours
Secondary	Surgeon Satisfaction	NASA-TLX quantification table will be used to evaluate surgeon satisfaction after surgery	12 hours