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

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.

Study Overview

• Status: Recruiting
• Conditions: Urological Surgeries
• Intervention / Treatment: Device: SP

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: Danfeng Xu; Phone Number: 666062 （021）64370045; Email: xdf12036@rjh.com.cn
      • Principal Investigator: Danfeng Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: SP; English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraoperative conversion rate	Intraoperative
incidence of device-related or likely related complications	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Intraoperative bleeding volume	Intraoperative
Surgical duration	Intraoperative
The rate of intraoperative blood transfusion	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

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: radical prostatectomy; partial nephrectomy; radical nephrectomy; SP single-port robot; radical resection of the renal pelvic carcinoma (one position); pyeloplasty and other single-port urological surgeries
• Other Study ID Numbers: ISFMT-SP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes