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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

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

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Overview

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.

Eligibility

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.

Study details
    Urological Surgeries

NCT06181942

Ruijin Hospital

26 January 2024

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