NCT06246617

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• da Vinci SP Surgical System
• Thoracic Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-25
• Primary completion: 2024-12-31
• Completion: 2025-01-28
• First posted: 2024-02-07
• Last updated: 2024-02-07

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study