NCT05150210

SP Thoracic IDE Study

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Robotic-Assisted Surgery	da Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease.

Timeline

• Start date: 2022-07-20
• Primary completion: 2023-06-16
• Completion: 2028-07-01
• First posted: 2021-12-09
• Last updated: 2025-12-23
• Results posted: 2025-12-23

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study