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

NCT06181942 | Unknown DMC FDA Device

• 1 other identifier: ISFMT-SP-001
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Urological Surgeries

Keywords

SP single-port robot; radical prostatectomy; partial nephrectomy; radical nephrectomy; radical resection of the renal pelvic carcinoma (one position); pyeloplasty and other single-port urological surgeries

Outcome Measures

Primary Outcomes (2)

• Intraoperative conversion rate

  Intraoperative

• incidence of device-related or likely related complications

  30 days

Secondary Outcomes (8)

• Intraoperative bleeding volume

  Intraoperative

• The rate of intraoperative blood transfusion

  Intraoperative

• Surgical duration

  Intraoperative

• Length of stay (LOS)

  up to 4 weeks

• Admission to ICU and ICU LOS

  up to 4 weeks

Study Arms (1)

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

Interventions

SP DEVICE

English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.

single-port urological surgeries with the SP single-port robot

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pro.Danfeng Xu

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: December 26, 2023
• Study Start: February 22, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

CN (1)