A Prospective, Multi-Center Investigation of the da Vinci SP Surgical System in Pulmonary and Lobectomy for Benign and Malignant Disease
Phase: NA
Conditions: Primary Lung Cancer, Benign Lung Disease, Thymoma, Myasthenia Gravis
Sponsor: Intuitive Surgical

 
 
A Prospective, Multi-Center Investigation of the da Vinci SP® 
Surgical System in Pulmonary Lobectomy and Thymectomy for 
Benign and Malignant Disease 
 
Protocol Summary 
NCT05150210 
 
Date: 8/15/2024 
 
 
SPONSOR: 
Intuitive Surgical, Inc. 
1020 Kifer Road 
Sunnyvale, CA 94086 
Telephone: (408) 523-2100 
Facsimile: (408) 523-1390 
 
 
 
 

 
 
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Study # 
dV SP – Thoracic-01 
Title 
A prospective, multi-center investigation of the da Vinci SP® Surgical System 
in pulmonary lobectomy and thymectomy for benign and malignant disease 
Study Design 
A prospective, multi-center, single-arm clinical investigation 
Study Center 
Up to six institutions will be included in the United States.  
Number of 
Subjects 
Up to N=36. The study will enroll a minimum of 18 pulmonary lobectomy 
cases, and a minimum of 10 thymectomy cases will additionally be enrolled. 
The study will be conducted in a staged approach, starting with enrollment of 
10 thymectomy cases in the first stage and followed by enrollment of  
lobectomy cases upon FDA approval to begin enrollment in the second stage. 
Study Objective To confirm the safety and performance of the da Vinci SP Surgical System, 
Instruments and Accessories in pulmonary lobectomy, and in thymectomy 
procedures 
Premarket 
Study 
Endpoints 
Primary Performance: 
• The primary performance 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 
 
Primary Pathology (malignant cases only): 
The primary pathologic endpoint will be assessed as the rate of complete 
resection (R0) at all surgical resection margins (for lung cancer: bronchial, 
parenchymal, vascular margins and for thymoma: pleural margins). 
 
 

 
 
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Pre-market 
Data Collection 
➢ Pre-operative Assessment: demographics (age, gender, race, 
ethnicity), patient characteristics (e.g. BMI, ASA class, functional 
status- Zubrod score), and medical history (e.g. tobacco use, 
occupational exposure, steroid use, comorbidities such as 
hypertension, cardiopulmonary disease, diabetes, pulmonary arterial 
hypertension), standard imaging and lab tests, pulmonary function 
tests (FEV1% predicted, DLCO% predicted), neo-adjuvant therapy, 
prior cardiothoracic surgery, pre-operative tumor characteristics 
(tumor size, location, clinical tumor staging) 
➢ Intra-operative Assessment: Operative time (wheels-in, wheels-out, 
robotic procedure time (docking time, console time), anesthesia time, 
primary procedure performed, secondary (concomitant) procedures 
performed, chest tube placement, estimated blood loss, blood 
transfusions, conversions, intraoperative adverse events 
➢ Post-operative (to discharge) Assessment: Post-operative adverse 
events, in-hospital mortality, length of hospital stay (LOS), patient 
disposition immediately after surgery (ICU, intermediate care unit, 
ward), length of intermediate care unit stay, length of ICU stay, 
chest tube duration, reason for prolonged placement, if applicable, 
amount of daily chest tube drainage, discharge disposition (such as 
another health care facility, nursing care, home, etc.), unplanned 
procedure-related reoperations 
➢ Post-operative (14 ± 3 days) Assessment: Unplanned procedure-
related reoperations or readmissions, mortality, post-operative 
adverse events, chest tube duration, reason for prolonged placement, 
and total amount of chest tube drainage, if applicable, pathologic 
tumor staging, surgical margins, number of harvested lymph nodes, 
lymph node stations  
➢ Post-operative (30 days ± 7 days) Assessment: Unplanned procedure-
related reoperations or readmissions, mortality, post-operative 
adverse events, chest tube duration, reason for prolonged placement, 
and total amount of chest tube drainage, if applicable 
Post-Market 
Assessment 
Long-term data out to 5 years will be collected from study subjects that 
underwent lobectomy for primary lung cancer or thymectomy for thymoma.  
The post-market long term data collection will include information on long-
term cancer outcomes such as local recurrence, disease free survival, overall 
survival, adverse events related to the index procedures, and any administered 
adjuvant therapy  
Study Eligibility 
Criteria 
General Inclusion Criteria: 
• Age >21 years 
• BMI ≤ 35 
• ASA ≤ 3 

 
 
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• 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 ≤ 
5 cm diameter 
 
Thymectomy Inclusion Criteria: 
• Masaoka clinical stage I or II thymoma; or thymectomy for myasthenia 
gravis; thymic mass ≤ 5 cm diameter 
 
General Exclusion Criteria: 
• Clinical or radiological evidence of mediastinal or systemic metastatic 
disease  
• Life expectancy < 6 months 
• Subjects 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  
 
 

 
 
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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 
Study Devices  
System: da Vinci SP Surgical System 
Instruments:  The EndoWrist SP Instruments available include: a needle 
driver, medium-large clip applier, monopolar curved scissors, monopolar 
cautery instrument, fenestrated bipolar forceps, Maryland bipolar forceps, 
Cadiere forceps, round tooth retractor and the Camera Instrument. 
Accessories available: The SP Accessories include: Cannula, Obturator, 
Entry Guide Kit, Sheaths for Camera and Instruments, tips for Monopolar 
Curved Scissors, Cautery Hook and Cautery Spatula, Instrument Arm Drape 
and cautery cords, SP Access Port Kit (Small Incision) and SP Access Port 
Kit (Large Incision) 
Sample Size 
Considerations 
The planned number of subjects in this confirmatory study (N=36) comprises 
a minimum of eighteen (n=18) lobectomy cases based on the anticipated 
intra-operative and post-operative lobectomy adverse event rate from prior 
literature, and includes a minimum of 10 cases of thymectomy. It is intended 
to provide a measure by which the performance and safety of the da Vinci SP 
Surgical System in a clinical setting can be confirmed based on animal and 
cadaver testing. 
Data Analysis  
All subjects will be included for analysis, regardless of the completeness of 
their data. Analyses will be based on pre-operative characteristics, intra-
operative and post-operative characteristics, and outcomes through 30 days 
of follow-up. 

 
 
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Study 
Enrollment 
& 
Follow Up 
Enrollment is anticipated to take approximately 13 – 15 months.  
 
Premarket Assessment: 
Subjects will be followed postoperatively at 14 days (± 3 days) and at 30 days 
(± 7 days).  
 
Post market Assessment (for malignant patients only): 
Subjects will be followed on a semiannual basis for the first two years and 
annually afterwards out to 5 years (± 90 days) post-operatively following 
National Comprehensive Cancer Network (NCCN) guidelines.