Clinical trial · Interventional
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
NCT05025930CI-TRIAL-00053650unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urologic Neoplasms | Urinary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopic surgical instrument control system (IS3000: multi-port laparoscopy) | Device | — | UNRESOLVED |
| endoscopic surgical instrument control system (SP1000: single-port laparoscopy) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- endoscopic surgical instrument control system (SP1000: single- port laparoscopy)
- description
- Urological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (SP1000)
- interventionNames
- Device: endoscopic surgical instrument control system (SP1000: single-port laparoscopy)
- type
- ACTIVE_COMPARATOR
- label
- Comparator: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)
- description
- Urological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (IS3000)
- interventionNames
- Device: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.