Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000).
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2021
CompletedFirst Posted
Study publicly available on registry
August 30, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedSeptember 2, 2021
August 1, 2021
2 years
July 9, 2021
August 29, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (10)
Perioperative complication rate
3 months
Changes in serum creatinine
3 months
Changes in prostate-specific antigen levels
3 months
Tumor recurrence rate
3 months
Machine installation time
preoperative
- +5 more secondary outcomes
Study Arms (2)
endoscopic surgical instrument control system (SP1000: single- port laparoscopy)
EXPERIMENTALUrological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (SP1000)
Comparator: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)
ACTIVE COMPARATORUrological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (IS3000)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tianxin Lin, MD
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2021
First Posted
August 30, 2021
Study Start
October 1, 2021
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
September 2, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share