Valuate the Clinical Performance and Safety of da Vinci SP Surgical System

Not Applicable

Recruiting

• Conditions: da Vinci SP Surgical System; Thoracic Surgery
• Interventions: Device: da Vinci SP Surgical System for Single-Port Thoracic Surgeries

• Registration Number: NCT06246617
• Lead Sponsor: Ruijin Hospital

Brief Summary

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 robot-assisted thoracic surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population.

Detailed Description

Subjects who have received or plan to receive pulmonary lobectomy/segmentectomy, mediastinal tumor resection (including thymectomy), radical resection of esophagus cancer or other surgeries with the SP single-port robot.

Study Timeline

• Study Start: 2023-10-25
• Status Verified: 2023-11
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-28

Recruitment & Eligibility

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

Inclusion Criteria

• 1. Subjects who have received or plan to receive pulmonary lobectomy/segmentectomy, mediastinal tumor resection (including thymectomy), radical resection of esophagus cancer or other 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

• 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 investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	da Vinci SP Surgical System for Single-Port Thoracic Surgeries	Subjects who have received or plan to receive pulmonary lobectomy/segmentectomy, mediastinal tumor resection (including thymectomy), radical resection of esophagus cancer or other surgeries with the SP single-port robot.

Primary Outcome Measures

Name	Time	Method
Intraoperative conversion rate	intraoperative	Intraoperative conversion rate = number of subjects with intraoperative conversion/total number of subjects ×100%.; The intraoperative conversion is defined as conversion to other procedures (including but not limited to traditional laparoscopic surgeries, other robot-assisted surgeries, open surgeries and so on) for various reasons during surgery

Trial Locations

Locations (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China