Robotic-Assisted Surgery: da Vinci SP Surgical System, instruments, and accessories in pulmonary lobectomy and thymectomy for benign and malignant disease.
Study summary
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.
Eligibility
Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Rate of Conversion — Intra-operative period Performance defined as the ability to complete the planned da Vinci SP-assisted pulmonary lobectomy and thymectomy procedures without conversion to an alternate approach
Major Adverse Event Rate — Intra-operative through the 30 days follow-up period Safety defined as the incidence of major intra-operative and post-operative adverse events that occur through the 30-day follow-up period.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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