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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

China15 participantsStarted 2023-02-22

Plain-language summary

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.

Who can participate

SexALL

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Inclusion 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

✕. 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.

What they're measuring

Intraoperative conversion rate

Timeframe: Intraoperative

incidence of device-related or likely related complications

Timeframe: 30 days

Trial details

NCT IDNCT06181942

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Urological Surgeries trials