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Clinical Trials in the USA / NCT05150210
Active, not recruiting Not applicable

SP Thoracic IDE Study

NCT05150210 · tracked via the Priya Life Science USA tracker
Sponsor
Intuitive Surgical
Phase
Not applicable
Started
2022-07-20
Last updated
2026-09-14

Condition(s) studied

Primary Lung CancerBenign Lung DiseaseThymomaMyasthenia Gravis

Investigational drug(s) / intervention(s)

Robotic-Assisted Surgery

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)

Trial sites (6)

FacilityCityRegionStatus
Cedars-Sinai Medical Center Los Angeles California
Brigham and Women's Hospital Boston Massachusetts
NYU Langone Health New York New York
Memorial Sloan Kettering Cancer Center New York New York
Duke University Hospital Durham North Carolina
MD Anderson Cancer Center Houston Texas

More Intuitive Surgical trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT05150210 on ClinicalTrials.gov ↗ ← All trials in the USA