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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

NCT ID: NCT06181942

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-22

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Urological Surgeries

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

SP

Intervention Type DEVICE

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

Interventions

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SP

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Danfeng Xu

Pro.Danfeng Xu

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Danfeng Xu

Role: primary

Other Identifiers

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ISFMT-SP-001

Identifier Type: -

Identifier Source: org_study_id