Robotic-Assisted Surgery for Lung Cancer and Thymoma

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen ByDavid Rice, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Intuitive Surgical

No Placebo Group

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.

Eligibility Criteria

Adults over 21 with a BMI ≤ 35, early-stage lung cancer or benign lung disease needing surgery, or thymoma/myasthenia gravis requiring thymectomy. Participants must consent to follow-ups for up to 5 years. Exclusions include bleeding disorders, heavy anticoagulant use, general anesthesia risks, prior thoracic treatments, short life expectancy (<6 months), pregnancy/breastfeeding, and recent immunotherapies.

Inclusion Criteria

My lung cancer is in an early stage (I or II) or I have a lung condition needing surgery, with the tumor being 5cm or smaller.

I can follow the study's schedule for check-ups and long-term follow-up for 5 years.

My thymoma is stage I or II, or I had a thymectomy for myasthenia gravis with a thymic mass ≤ 5 cm.

+4 more

Exclusion Criteria

My myasthenia gravis symptoms are not under control before my thymectomy.

My cancer has spread to my chest area or other parts of my body.

Subject is pregnant or suspected to be pregnant or breastfeeding

+16 more

Participant Groups

The trial is testing the safety and effectiveness of the da Vinci SP Surgical System for pulmonary lobectomy in patients with lung conditions and thymectomy in those with thymoma or myasthenia gravis. The study involves post-operative assessments at specific intervals after surgery.

1Treatment groups

Experimental Treatment

Group I: SP Surgical SystemExperimental Treatment1 Intervention

Pulmonary lobectomy and thymectomy procedures will be performed by da Vinci SP Surgical System.

da Vinci SP Surgical System is already approved in United States for the following indications:

🇺🇸 Approved in United States as da Vinci SP Surgical System for:

Urological procedures including radical prostatectomy, pyeloplasty, nephrectomy, partial nephrectomy
Simple prostatectomy for benign prostatic hyperplasia (BPH) or enlarged prostate
Transvesical approach to simple and radical prostatectomy