A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries

Study Overview
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Brief Summary
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Study name：A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries； Study purpose：This clinical trial is a real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System (SP single-port robot for short) for single-port urological robotic surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population. Study design：Retrospective + prospective, real-world study Investigational medical device： English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.

Official Title
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A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries

Conditions
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Urological Surgeries

Intervention / Treatment
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* Device: SP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects should meet all the following criteria: 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; 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. Patients with missing data on the primary endpoint in retrospective cases; Subjects having any contraindications of single-port robot surgery; The intraoperative anatomy determined that minimally invasive surgery was not suitable; Patients who are considered inappropriate to participate in this Study by investigators.
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single-port urological surgeries with the SP single-port robot<br>who have received or plan to receive radical prostatectomy (RP), partial nephrectomy (PN), radical nephrectomy (RN), radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological surgeries with the SP single-port robot. | Device: SP<br>* English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative conversion rate |  | Intraoperative | 
| incidence of device-related or likely related complications |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative bleeding volume |  | Intraoperative | 
| The rate of intraoperative blood transfusion |  | Intraoperative | 
| Surgical duration |  | Intraoperative | 
| Length of stay (LOS) |  | up to 4 weeks | 
| Admission to ICU and ICU LOS |  | up to 4 weeks | 
| Urethral catheter indwelling duration |  | up to 4 weeks | 
| Postoperative pain score |  | follow-ups 1 day (24±4 hours), 3 days (72±4 hours) and 1 month (30±5 days) after the surgery. | 
| Short-term recovery of functions for1 )Erectile function and 2)Urinary continence function |  | in the follow-up 1 month after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SP single-port robot, radical prostatectomy, partial nephrectomy, radical nephrectomy, radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological surgeries