Trials / Unknown
UnknownNCT05025930
Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000).
Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000): a Multi-center, Randomized, Single-blind, Parallel Controlled Clinical Tria
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DEVICE | 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. |
Timeline
- Start date
- 2021-10-01
- Primary completion
- 2023-09-30
- Completion
- 2023-09-30
- First posted
- 2021-08-30
- Last updated
- 2021-09-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05025930. Inclusion in this directory is not an endorsement.