SP Thoracic IDE Study

Myasthenia Gravis Clinical Trial

Official title: A Prospective, Multi-Center Investigation of the da Vinci SP Surgical System in Pulmonary and Lobectomy for Benign and Malignant Disease

Status Active, not recruiting

Clinical Trial Summary

To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.

Clinical Trial Description

Primary performance:

The primary endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted thoracic procedure without conversion to an alternate approach. Conversion to an alternate approach comprises undocking of the da Vinci SP to complete the planned procedures using other methods, such as open, VATS, or multiport robotic (da Vinci SI or X/Xi)

Primary Safety:

The primary safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period. ;

Related Conditions & MeSH terms

• Benign Lung Disease
• Lung Diseases
• Myasthenia Gravis
• Primary Lung Cancer
• Thymoma

• NCT number: NCT05150210
• Study type: Interventional
• Source: Intuitive Surgical
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 20, 2022
• Completion date: July 2028