Evaluating the da Vinci SP Surgical System for Urological Surgeries
A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries
Ruijin Hospital · NCT06181942
This study tests how well the da Vinci SP Surgical System works and keeps patients safe during urological surgeries like prostate and kidney removal in real-life settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Sex | All |
| Sponsor | Ruijin Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06181942 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical performance and safety of the da Vinci SP Surgical System, a single-port robotic surgical device, specifically for urological surgeries such as radical prostatectomy and nephrectomy. It employs a real-world study design that includes both retrospective and prospective data collection to provide evidence of the system's effectiveness in the Chinese population. The goal is to assess how well this technology performs in actual clinical settings, rather than controlled environments.
Who should consider this trial
Good fit: Ideal candidates include patients who are scheduled for or have undergone single-port urological robotic surgeries using the da Vinci SP Surgical System.
Not a fit: Patients with contraindications for single-port robotic surgery or those deemed inappropriate for participation by investigators may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes and safety for patients undergoing urological surgeries using advanced robotic technology.
How similar studies have performed: Other studies have shown promising results with robotic surgical systems, but this specific evaluation of the da Vinci SP Surgical System is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects should meet all the following criteria: 1. Subjects who have received or plan to receive RP, PN, RN, radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological robotic surgeries with the SP single-port robot; 2. Patients who voluntarily decide to participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC). Exclusion Criteria: The subjects meeting any of the following criteria should be excluded. 1. Patients with missing data on the primary endpoint in retrospective cases; 2. Subjects having any contraindications of single-port robot surgery; 3. The intraoperative anatomy determined that minimally invasive surgery was not suitable; 4. Patients who are considered inappropriate to participate in this Study by investigators.
Where this trial is running
Shanghai, Shanghai
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urological Surgeries, SP single-port robot, radical prostatectomy, partial nephrectomy, radical nephrectomy, radical resection of the renal pelvic carcinoma, pyeloplasty and other single-port urological surgeries