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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-port urological surgeries with the SP single-port robot | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP | Device | English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative conversion rate | Intraoperative | |
| incidence of device-related or likely related complications | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative bleeding volume | Intraoperative | |
| The rate of intraoperative blood transfusion | Intraoperative | |
| Surgical duration |
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Inclusion Criteria:
Subjects should meet all the following criteria:
Exclusion Criteria:
The subjects meeting any of the following criteria should be excluded.
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Subjects 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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| 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 |