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

Recruiting

• Conditions: Urological Surgeries
• Interventions: Device: SP

• Registration Number: NCT06181942
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-22
• Study First Submitted: 2023-08-17
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-13
• Last Update Submitted: 2023-12-13
• Study First Posted: 2023-12-26
• Last Update Posted: 2023-12-26
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single-port urological surgeries with the SP single-port robot	SP	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.

Primary Outcome Measures

Name	Time	Method
Intraoperative conversion rate	Intraoperative
incidence of device-related or likely related complications	30 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China