SP Thoracic IDE Study

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Primary Lung Cancer, Benign Lung Disease, Thymoma, Myasthenia Gravis

Intervention / Treatment
-----------------
* Device: Robotic-Assisted Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 21 years BMI ≤ 35 ASA ≤ 3 Willing and able to provide a written informed consent Willing and able to comply with the study protocol requirements including follow-up examinations at 14 days and 30 days post-operatively, and post-market long term follow-up on an annual basis through 5 years Lobectomy Inclusion Criteria: - Clinical stage I or II primary lung cancer or other suspected lung malignancy; or benign lung disease requiring resection; primary tumor ≤ 5cm diameter Thymectomy Inclusion Criteria: - Masaoka clinical stage I or II thymoma; or thymectomy for myasthenia gravis; thymic mass ≤ 5 cm diameter Exclusion Criteria: Clinical or radiological evidence of mediastinal or systemic metastatic disease Life expectancy < 6 months Subject with a known bleeding or clotting disorder Subjects actively receiving therapeutic-dose anticoagulation or anti-platelet medications at the time of operation Uncontrolled systemic illness 6 months prior to planned surgical procedure including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Previous chemotherapy, immunotherapy and/or radiation therapy for treatment of the cancer to be resected Subject has a contraindication for general anesthesia or surgery Subjects under active immunomodulatory or immunosuppressive regimen (e.g. transplant patient, high-dose steroid requirement) within 30 days prior to the planned surgical procedure. For myasthenia patients, if steroids are weaned down to prednisone ≤ 5 mg/day prior to day of surgery, the patient may be enrolled Previous sternotomy Subject belongs to vulnerable population Subject is pregnant or suspected to be pregnant or breastfeeding Lobectomy Exclusion Criteria: Tumor involving carina or any airway requiring sleeve resection, bronchoplasty Tumor requiring resection of local structures (e.g. chest wall) or extended resection such as bilobectomy History of pulmonary hypertension Previous ipsilateral thoracic surgery or radiotherapy Thymectomy Exclusion Criteria: Uncontrolled myasthenia gravis symptoms at the time of scheduled surgery Tumor requiring resection of local structures (except pericardium) Confirmed thymic carcinoma Intraoperative Exclusion Criteria: - Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SP Surgical System<br>Pulmonary lobectomy and thymectomy procedures will be performed by da Vinci SP Surgical System. | Device: Robotic-Assisted Surgery<br>* da Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Conversion | Performance defined as the ability to complete the planned da Vinci SP-assisted pulmonary lobectomy and thymectomy procedures without conversion to an alternate approach | Intra-operative period | 
| Adverse Event Rate | Safety defined as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period. | Intra-operative through the 30 days follow-up period |