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Robotic Surgery
Robotic-Assisted Surgery for Lung Cancer and Thymoma
N/A
Waitlist Available
Led By David Rice, MD
Research Sponsored by Intuitive Surgical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical stage I or II primary lung cancer or other suspected lung malignancy; or benign lung disease requiring resection; primary tumor ≤ 5cm diameter (Lobectomy)
Masaoka clinical stage I or II thymoma; or thymectomy for myasthenia gravis; thymic mass ≤ 5 cm diameter (Thymectomy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intra-operative through the 30 days follow-up period
Awards & highlights
Study Summary
This trial is testing the da Vinci SP surgical system to see if it is safe and effective for pulmonary lobectomy (removal of a lobe of the lung) and thymectomy (removal of the thymus) procedures.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical surgical risks such as pain at the incision site, infection risk from surgery, bleeding complications, reactions to anesthesia and possible damage to surrounding tissues during robotic-assisted procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
My thymoma is stage I or II, or I had a thymectomy for myasthenia gravis with a thymic mass ≤ 5 cm.
Select...
I am older than 21 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intra-operative period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intra-operative period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Event Rate
Rate of Conversion
Trial Design
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.
Find a Location
Who is running the clinical trial?
Intuitive SurgicalLead Sponsor
73 Previous Clinical Trials
49,227 Total Patients Enrolled
David Rice, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My myasthenia gravis symptoms are not under control before my thymectomy.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 cancer has spread to my chest area or other parts of my body.You are not expected to live for more than 6 months.I have had chemotherapy, immunotherapy, or radiation for my cancer.I am currently taking medication to prevent blood clots.I cannot undergo surgery or general anesthesia due to health risks.My tumor needs surgery that may involve removing nearby structures.My tumor needs surgery that may involve removing part of the chest wall or a large section of the lung.I haven't had any major health issues like heart problems or severe infections in the last 6 months.I am not on strong immune system medications, or if I am, it's low-dose prednisone.My thymoma is stage I or II, or I had a thymectomy for myasthenia gravis with a thymic mass ≤ 5 cm.My surgery cannot be done with minimally invasive techniques.I am older than 21 years.I have had surgery or radiation therapy on the same side of my chest before.I have been diagnosed with thymic carcinoma.I have a condition that affects my blood's ability to clot.I have had high blood pressure in the lungs and a lung surgery.Your body mass index (BMI) is 35 or lower.My tumor affects the airways and may need complex surgery.I have had open-heart surgery before.Your health condition is serious, with a score of 3 or less on the ASA scale.
Research Study Groups:
This trial has the following groups:- Group 1: SP Surgical System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for this research endeavor currently?
"According to the clinicaltrials.gov platform, this medical trial is currently recruiting participants; it was originally posted on July 20th 2022 and recently updated on October 21st 2022."
Answered by AI
How many individuals have enrolled in the clinical research thus far?
"Affirmative. Clinicaltrials.gov data evinces that this clinical trial, initially launched on July 20th 2022, is presently seeking out patients to participate. 30 participants need to be recruited from 6 distinct medical facilities."
Answered by AI
How many centers are actively managing this trial?
"Patients interested in participating in this medical trial may apply at any of the 9 locations, including Cedars-Sinai Medical Center (Tarzana, CA), Duke University Hospital (Durham, NC), and NYU Langone Health (New york City)."
Answered by AI
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