Robotic-Assisted Surgery for Lung Cancer and Thymoma

Not currently recruiting at 6 trial locations

Overseen By Ling Lin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Intuitive Surgical

Must not be taking: Anticoagulants, Antiplatelets, Immunosuppressants

Disqualifiers: Metastatic disease, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Intra-operative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and performance of the da Vinci SP Surgical System for specific lung and thymus surgeries. The system performs procedures such as removing part of the lung or the thymus, a gland in the chest. Suitable candidates include those with stage I or II lung cancer, a thymic mass, or myasthenia gravis, who require surgery. The trial does not suit individuals with more advanced cancer, certain heart or lung conditions, or recent cancer treatments. As an unphased trial, participants contribute to advancing surgical technology and may benefit from cutting-edge robotic procedures.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on certain medications like high-dose steroids or therapeutic-dose anticoagulation at the time of surgery. If you have myasthenia gravis, you may need to reduce steroids to a low dose before surgery.

What prior data suggests that the da Vinci SP Surgical System is safe for pulmonary lobectomy and thymectomy procedures?

Research has shown that the da Vinci SP Surgical System is safe and effective across various surgeries. A review of 55 studies found that surgeries using the da Vinci system often result in less blood loss and fewer blood transfusions, indicating the system's gentle impact on the body.

Other studies have demonstrated that the da Vinci single-port system is safe and effective for lung surgery, including procedures for lung cancer and thymoma (a type of tumor in the thymus gland), with promising results.

The system's precision in movement makes surgeries less invasive, potentially leading to quicker recoveries and fewer complications. Overall, safety data from previous research reassures those considering participation in a clinical trial involving this surgical system. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the da Vinci SP Surgical System for lung cancer and thymoma because it offers a less invasive surgical option compared to traditional open surgeries or standard minimally invasive techniques. This robotic-assisted system features a single-port design that allows for more precise and flexible movements in confined spaces, which can potentially reduce recovery time and improve surgical outcomes. Unlike conventional methods, which may require larger incisions or multiple entry points, the da Vinci SP system is designed to minimize trauma to the body, enhancing the patient's overall surgical experience.

What evidence suggests that the da Vinci SP Surgical System is effective for lung cancer and thymoma?

Research has shown that the da Vinci SP Surgical System, which participants in this trial will experience, is effective for chest surgeries, such as removing parts of the lung or the thymus gland, using just one small incision. A review of 55 studies found that surgeries with this robotic system resulted in less blood loss and fewer blood transfusions. Studies also showed it reduces the need to switch from robotic to traditional surgery methods. Initial experiences with 115 patients using this system for chest surgeries further support its effectiveness and safety. Overall, the da Vinci SP system appears promising for surgeries related to lung cancer and thymoma. ^{1 3 4 5 6}

Who Is on the Research Team?

David Rice, M.D.

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

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

Subject is pregnant or suspected to be pregnant or breastfeeding

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pulmonary lobectomy and thymectomy procedures using the da Vinci SP Surgical System

Intra-operative period

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• da Vinci SP Surgical System

Trial Overview 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.

How Is the Trial Designed?

Group I: SP Surgical System Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Intuitive Surgical

Lead Sponsor

Trials

80

Recruited

49,600+

Gary Guthart

Intuitive Surgical

Chief Executive Officer since 2010

PhD in Engineering, California Institute of Technology

Henry Charlton

Intuitive Surgical

Chief Medical Officer since 2023

MD from an unspecified institution

Published Research Related to This Trial

The da Vinci SP® surgical system was evaluated in a study involving 50 patients undergoing various colorectal procedures, demonstrating significant reductions in operative time as experience with the system increased, indicating improved efficiency.

The study found that the dVSP system is safe for colorectal surgery, with only six mild adverse events reported and no local recurrences, suggesting it is a promising option for oncological procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-incision robotic colorectal surgery with the da Vinci SP® surgical system: initial results of 50 cases. Kim, HS., Oh, BY., Cheong, C., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12296386/

Single-Port Robotic-Assisted Approach in Thoracic Surgery This study evaluated the effectiveness and safety of the da Vinci single-port surgical system for thoracic surgery in a Chinese population ( ...

2. withpower.com withpower.com/trial/robotic-assisted-surgery-for-lung-cancer-and-thymoma-91d28

Robotic-Assisted Surgery for Lung Cancer and Thymoma The da Vinci SP system has shown promise in thoracic surgeries, such as lung resections and thymectomies, by allowing procedures through a single small incision ...

3. intuitive.com intuitive.com/en-us/about-us/company/research-outcomes

Da Vinci Research and Outcomes A review of 55 studies found robotic-assisted surgery (RAS) with the da Vinci system led to lower blood loss, fewer conversions, fewer blood transfusions, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S002252232400206X

Robotic thoracic surgery using the single-port robotic system This study aimed to report the initial experiences of 115 patients who underwent robotic thoracic surgery using the da Vinci single-port robotic surgical ...

5. jtcvs.org jtcvs.org/article/S0022-5223(24)00206-X/abstract

Robotic thoracic surgery using the single-port robotic system This study aimed to report the initial experiences of 115 patients who underwent robotic thoracic surgery using the da Vinci single-port ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0003497525004205

Safety and Feasibility of Novel Single-Port Robotic ... Robotic-assisted thoracic surgery (RATS) has advanced lung cancer treatment with precise robotic arm maneuvers and 3-dimensional ...