Clinical trial NCT05025930: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Urologic Neoplasms
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
name: The First Affiliated Hospital of Nanchang University
name: Edge Medical Robotics CO.,LTD
First posted: 2021-08-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Surgical success rate
timeFrame: 24 hours
measure: Incidence of serious adverse events during clinical trial
timeFrame: 3 months
Secondary outcomes:
measure: Perioperative complication rate
timeFrame: 3 months
measure: Changes in serum creatinine
timeFrame: 3 months
measure: Changes in prostate-specific antigen levels
timeFrame: 3 months
measure: Tumor recurrence rate
timeFrame: 3 months
measure: Machine installation time
timeFrame: preoperative
measure: Operative time
timeFrame: 12 hours
measure: Blood loss during the surgery
timeFrame: 12 hours
measure: Margin positive rate
timeFrame: 1 month
measure: Pain after surgery
timeFrame: 24 hours
measure: Surgeon Satisfaction
timeFrame: 12 hours
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Tianxin Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: