Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000): a Multi-center, Randomized, Single-blind, Parallel Controlled Clinical Tria
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Surgical success rate
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Surgical success rate
Time Frame: 24 hours
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
Time Frame: 3 months
Secondary Outcomes
- Operative time(12 hours)
- Machine installation time(preoperative)
- Changes in prostate-specific antigen levels(3 months)
- Tumor recurrence rate(3 months)
- Perioperative complication rate(3 months)
- Changes in serum creatinine(3 months)
- Pain after surgery(24 hours)
- Surgeon Satisfaction(12 hours)
- Blood loss during the surgery(12 hours)
- Margin positive rate(1 month)