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To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP Surgical System- Lobectomy procedures | Experimental | Pulmonary lobectomy performed by da Vinci SP Surgical System. |
|
| SP Surgical System - Thymectomy | Experimental | Thymectomy procedures performed by the da Vinci SP Surgical System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-Assisted Surgery | Device | da Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease. |
|
| 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 |
| Major Adverse Event Rate | Safety defined as the incidence of major 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 |
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Inclusion Criteria:
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:
Lobectomy Exclusion Criteria:
Thymectomy Exclusion Criteria:
Intraoperative Exclusion Criteria:
- Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
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| Name | Affiliation | Role |
|---|---|---|
| David Rice, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40216299 | Derived | Zervos M, Park BJ, Marshall MB, Wee JO, Soukiasian HJ, Hartwig MG, Rajaram R, Rice DC. Robotic-assisted single-port system for pulmonary lobectomy: A prospective feasibility study. J Thorac Cardiovasc Surg. 2025 Jul;170(1):54-60.e1. doi: 10.1016/j.jtcvs.2025.04.004. Epub 2025 Apr 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SP Surgical System -Thymectomy | Thymectomy procedures performed by da Vinci SP Surgical System. |
| FG001 | SP Surgical System - Lobectomy | Lobectomy procedures performed by the SP Surgical System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SP Surgical System - Thymectomy | Pulmonary thymectomy procedures performed by da Vinci SP Surgical System. |
| BG001 | SP Surgical System - Lobectomy | Pulmonary lobectomy procedures performed by da Vinci SP Surgical System. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Thymectomy and Lobectomy groups were analyzed separately, including analysis for Age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 0 Conversions occured | Posted | Count of Participants | Participants | Intra-operative period |
|
Through the 30 day follow up period.
Major adverse events: Clavien-Dindo Grade III or higher
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SP Surgical System- Thymectomy | Thymectomy procedures performed by da Vinci SP Surgical System. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Air Leakage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraoperative Adverse Event | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Virk | Intuitive | 1 480-676-3938 | SP.Thoracic@intusurg.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2024 | Sep 5, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D013945 | Thymoma |
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
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| Boston |
| Massachusetts |
| 02115 |
| United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Major Adverse Event Rate | Safety defined as the incidence of major intra-operative and post-operative adverse events that occur through the 30-day follow-up period. | Posted | Count of Participants | Participants | Intra-operative through the 30 days follow-up period |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 5 |
| 32 |
| EG001 | SP Surgical System- Pulmonary Lobectomy | Pulmonary lobectomy procedures performed by da Vinci SP Surgical System. | 0 | 19 | 4 | 19 | 5 | 19 |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Non-serious AE | General disorders | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|