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

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246617
• Other study ID #: RTS-020
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: January 28, 2025

Study information

• Verified date: November 2023
• Source: Ruijin Hospital
• Contact: Hecheng Li
• Phone: +862164370045
• Email: lhc11863[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Thoracic Surgery

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	Intuitive Surgical

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative conversion rate	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	intraoperative