Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000).
Primary Purpose
Urologic Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endoscopic surgical instrument control system (SP1000: single-port laparoscopy)
endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)
Sponsored by
About this trial
This is an interventional treatment trial for Urologic Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Any male or female age from 18 to 80
- BMI 18-30kg/m2
- Have urological surgery indications (cystectomy, prostatectomy, and nephrectomy)
- Patients with physiologic conditions capable of receiving laparoscopic surgery
- Be able to cooperate and complete the follow-up and related examinations
- Volunteer to participate in this study and sign the informed consen
Exclusion Criteria:
- The researchers assess patients with severe cardiovascular or circulatory disease and cannot tolerate the surgery
- History of epilepsy or mental illness
- Pregnant and lactation
- Surgery history at the relevant surgical site, which is considered to influence surgical procedures
- Severe allergic or addiction of drug and alcohol
- Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastasis disease
- Inability to understand the trial or complete the follow-up
- Participated in other therapeutic clinical trials within 90 days
- 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
- Patients deemed unsuitable to participate in this trial by researchers
Sites / Locations
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
endoscopic surgical instrument control system (SP1000: single- port laparoscopy)
Comparator: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)
Arm Description
Urological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (SP1000)
Urological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (IS3000)
Outcomes
Primary Outcome Measures
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
Incidence of serious adverse events during clinical trial
Secondary Outcome Measures
Perioperative complication rate
Perioperative complication will be graded using the Clavien-Dindo Complication Classification. The proportion and severity of perioperative complications will be analyzed
Changes in serum creatinine
Evaluating renal function by changes in serum creatinine after surgery for partial or radical nephrectomy
Changes in prostate-specific antigen levels
Changes in prostate-specific antigen levels will be measured after surgery for patients who undergone radical prostatectomy
Tumor recurrence rate
Machine installation time
Time from sheeting to complete the installation of surgical instruments
Operative time
Blood loss during the surgery
Margin positive rate
Pain after surgery
Visual analogue scale as a monitoring tool for postoperative pain
Surgeon Satisfaction
NASA-TLX quantification table will be used to evaluate surgeon satisfaction after surgery
Full Information
NCT ID
NCT05025930
First Posted
July 9, 2021
Last Updated
August 29, 2021
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators
Chinese PLA General Hospital, The First Affiliated Hospital of Nanchang University, Edge Medical Robotics CO.,LTD
1. Study Identification
Unique Protocol Identification Number
NCT05025930
Brief Title
Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000).
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators
Chinese PLA General Hospital, The First Affiliated Hospital of Nanchang University, Edge Medical Robotics CO.,LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
endoscopic surgical instrument control system (SP1000: single- port laparoscopy)
Arm Type
Experimental
Arm Description
Urological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (SP1000)
Arm Title
Comparator: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)
Arm Type
Active Comparator
Arm Description
Urological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (IS3000)
Intervention Type
Device
Intervention Name(s)
endoscopic surgical instrument control system (SP1000: single-port laparoscopy)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Surgical success rate
Description
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
Time Frame
24 hours
Title
Incidence of serious adverse events during clinical trial
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Perioperative complication rate
Description
Perioperative complication will be graded using the Clavien-Dindo Complication Classification. The proportion and severity of perioperative complications will be analyzed
Time Frame
3 months
Title
Changes in serum creatinine
Description
Evaluating renal function by changes in serum creatinine after surgery for partial or radical nephrectomy
Time Frame
3 months
Title
Changes in prostate-specific antigen levels
Description
Changes in prostate-specific antigen levels will be measured after surgery for patients who undergone radical prostatectomy
Time Frame
3 months
Title
Tumor recurrence rate
Time Frame
3 months
Title
Machine installation time
Description
Time from sheeting to complete the installation of surgical instruments
Time Frame
preoperative
Title
Operative time
Time Frame
12 hours
Title
Blood loss during the surgery
Time Frame
12 hours
Title
Margin positive rate
Time Frame
1 month
Title
Pain after surgery
Description
Visual analogue scale as a monitoring tool for postoperative pain
Time Frame
24 hours
Title
Surgeon Satisfaction
Description
NASA-TLX quantification table will be used to evaluate surgeon satisfaction after surgery
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any male or female age from 18 to 80
BMI 18-30kg/m2
Have urological surgery indications (cystectomy, prostatectomy, and nephrectomy)
Patients with physiologic conditions capable of receiving laparoscopic surgery
Be able to cooperate and complete the follow-up and related examinations
Volunteer to participate in this study and sign the informed consen
Exclusion Criteria:
The researchers assess patients with severe cardiovascular or circulatory disease and cannot tolerate the surgery
History of epilepsy or mental illness
Pregnant and lactation
Surgery history at the relevant surgical site, which is considered to influence surgical procedures
Severe allergic or addiction of drug and alcohol
Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastasis disease
Inability to understand the trial or complete the follow-up
Participated in other therapeutic clinical trials within 90 days
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
Patients deemed unsuitable to participate in this trial by researchers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaiwen Li, MD
Phone
+86-02034078960
Email
likw6@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tianxin Lin, MD
Organizational Affiliation
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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