Clinical trial · Interventional
SP Thoracic IDE Study
A Prospective, Multi-Center Investigation of the da Vinci SP Surgical System in Pulmonary and Lobectomy for Benign and Malignant Disease
NCT05150210CI-TRIAL-00099491active not recruitingN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Lung Disease | — | UNRESOLVED | — |
| Myasthenia Gravis | — | UNRESOLVED | — |
| Primary Lung Cancer | — | UNRESOLVED | — |
| Thymoma | Thymoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic-Assisted Surgery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SP Surgical System- Lobectomy procedures
- description
- Pulmonary lobectomy performed by da Vinci SP Surgical System.
- interventionNames
- Device: Robotic-Assisted Surgery
- type
- EXPERIMENTAL
- label
- SP Surgical System - Thymectomy
- description
- Thymectomy procedures performed by the da Vinci SP Surgical System
- interventionNames
- Device: Robotic-Assisted Surgery
Primary outcomes (2)
- measure
- Rate of Conversion
- timeFrame
- Intra-operative period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZervos 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. PMID 40216299