Robotic-Assisted Surgery for Lung Cancer and Thymoma

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

32 Participants Needed

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.

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 data supports the effectiveness of the treatment da Vinci SP Surgical System 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, which can lead to less pain and quicker recovery. Initial studies and preclinical trials have demonstrated its feasibility and potential benefits in similar surgeries, suggesting it could be effective for lung cancer and thymoma. ^{1 2 3 4 5}

Is robotic-assisted surgery with the da Vinci SP system generally safe for humans?

The da Vinci SP system has been used in various surgeries, including colorectal and thoracic procedures, with studies assessing its safety and performance. Initial results suggest it is generally safe, but more research is needed to confirm its safety across different types of surgeries. ^{1 2 3 4 6}

How is the da Vinci SP Surgical System treatment different from other treatments for lung cancer and thymoma?

The da Vinci SP Surgical System is unique because it uses a single small incision for robotic-assisted surgery, which can reduce the invasiveness compared to traditional multi-port surgeries. This system allows surgeons to access hard-to-reach areas like the mediastinum (the central part of the chest cavity) more easily and safely, potentially improving surgical outcomes for lung cancer and thymoma. ^{1 2 3 7 8}

Research Team

David Rice, M.D.

Principal Investigator

M.D. Anderson Cancer Center

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Single-port robotic surgery for mediastinal tumors using the da vinci SP system: Initial experience. [2022]

2. China pubmed.ncbi.nlm.nih.gov

Initial experience with and surgical outcomes of da Vinci single-port system in general thoracic surgery. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Preclinical Feasibility Study of Single-Port Robotic Subcostal Anatomical Lung Resection and Subxiphoid Thymectomy Using the da Vinci&#174; SP System. [2023]

4. China pubmed.ncbi.nlm.nih.gov

Multi-institutional surgical outcomes of robotic single-port surgery: a Korean experience. [2023]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Da Vinci SP Single-Port Robotic Surgery in Gynecologic Tumors: Single Surgeon's Initial Experience with 100 Cases. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Single-incision robotic colorectal surgery with the da Vinci SP® surgical system: initial results of 50 cases. [2023]

7. China pubmed.ncbi.nlm.nih.gov

[Survival Analysis of Stage I Non-small Cell Lung Cancer Patients Treated with Da Vinci Robot-assisted Thoracic Surgery]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Appropriate set-up of the da Vinci Surgical System in relation to the location of anterior and middle mediastinal tumors. [2016]