SP Thoracic IDE Study
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.
Checked against the public recordLast updated Dec 23, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Other
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Intuitive Surgical
- Interventions being studied
- Device: Robotic-Assisted Surgery
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Cedars-Sinai Medical CenterLos Angeles, California
- Brigham and Women's HospitalBoston, Massachusetts
- NYU Langone HealthNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Duke University HospitalDurham, North Carolina
- MD Anderson Cancer CenterHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 23, 2025. Always confirm current availability with the study team.