A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urological Surgeries
- Sponsor
- Ruijin Hospital
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Intraoperative conversion rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Danfeng Xu
Pro.Danfeng Xu
Ruijin Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Intraoperative conversion rate
Time Frame: Intraoperative
incidence of device-related or likely related complications
Time Frame: 30 days
Secondary Outcomes
- Urethral catheter indwelling duration(up to 4 weeks)
- Intraoperative bleeding volume(Intraoperative)
- The rate of intraoperative blood transfusion(Intraoperative)
- Admission to ICU and ICU LOS(up to 4 weeks)
- Short-term recovery of functions for1 )Erectile function and 2)Urinary continence function(in the follow-up 1 month after the surgery)
- Postoperative pain score(follow-ups 1 day (24±4 hours), 3 days (72±4 hours) and 1 month (30±5 days) after the surgery.)
- Surgical duration(Intraoperative)
- Length of stay (LOS)(up to 4 weeks)