Comparing Outcomes for Minimally Invasive Techniques for Anatomic Lung Resection for Cancer - A Prospective, Comparative, Non-randomized, Open Label Post-market Observational Cohort Study Within Europe

Comparing Robotic vs. Traditional Surgery for Early Lung Cancer

NCT: NCT06038227 · Status: RECRUITING · Phase: N/A · Sponsor: Intuitive Surgical · Started: 2023-07-15 · Est. Completion: 2027-12-30

Plain English Summary

Lung cAncer Robotic Comparative Study is a Not Applicable clinical trial sponsored by Intuitive Surgical studying Lung Cancer. This study compares robotic-assisted surgery with traditional minimally invasive surgery for early-stage lung cancer. It is for patients diagnosed with early-stage non-small cell lung cancer. Participation involves undergoing either robotic or traditional minimally invasive surgery and follow-up assessments. Alternatives include traditional open surgery or other minimally invasive approaches not specifically studied here. The trial aims to enroll 512 participants.

Official Summary

To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with early-stage (IA1-2) non-small cell lung cancer can join. Patients must be at least 18 years old and able to consent and comply with study requirements. Patients with more advanced lung cancer (stage IA3 or higher), those needing emergency surgery, or those with metastatic cancer cannot join. Pregnant individuals or those planning pregnancy during the study, and individuals with a life expectancy less than 12 months are excluded. This trial is studying Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures assess how patients feel and function one month after surgery, indicating the impact of the surgical approach on their well-being. The specific primary outcome measures are: Patient reported Quality of Life 1 (1 month post surgery); Patient reported Quality of Life 2 (1 month post surgery). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to determine if robotic surgery offers better outcomes than traditional minimally invasive surgery for early lung cancer, potentially improving patient recovery and This research targets Lung Cancer, where improved treatment options are needed.

Investor Insight

This study, sponsored by Intuitive Surgical (a leader in robotic surgery), investigates the comparative effectiveness of their technology, suggesting a focus on demonstrating the value of robotic-assi The large enrollment target of 512 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific type of minimally invasive surgery planned (robotic vs. VATS) and why it's recommended for you. Understand that you will be monitored closely after surgery, including assessments of your quality of life. Be prepared for potential follow-up appointments and questionnaires to track your recovery. This trial is currently recruiting participants. The trial is being conducted at 12 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Patient diagnosed with clinical stage IA1-2 non-small cell lung cancer at time of procedure
* Patient scheduled to undergo minimally invasive surgery for NSCLC with either da Vinci robotic assisted surgery or VATs
* Aged ≥ 18 years
* Must be willing and able to comply with study requirements
* Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form

Exclusion Criteria:

* Patients with clinical stage IA3, II, III, and IV lung cancer
* Patient receiving a lobectomy/segmentectomy as an emergency procedure
* Patients receiving a lobectomy/segmentectomy for metastatic cancer
* Patients scheduled to receive a bilobectomy or sleeve-lobectomy
* Mental incapacity to understand or consent to study procedures
* Anticipated difficulty for patient to comply with protocol requirements
* Unable to comply with the follow up schedule
* Pregnant or are planning to become pregnant during the study
* Life expectancy \< 12 months

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06038227?

NCT06038227 is a Not Applicable OBSERVATIONAL study titled "Lung cAncer Robotic Comparative Study." It is currently recruiting and is sponsored by Intuitive Surgical. The trial targets enrollment of 512 participants.

What conditions does NCT06038227 study?

This trial investigates treatments for Lung Cancer. The primary condition under study is Lung Cancer.

What treatments are being tested in NCT06038227?

The interventions being studied include: Robotic Assisted Thoracic Surgery (PROCEDURE), Video Assisted Thoracic Surgery (PROCEDURE). Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.

What does Not Applicable mean for NCT06038227?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT06038227?

This trial is currently "Recruiting." It started on 2023-07-15. The estimated completion date is 2027-12-30.

Who is sponsoring NCT06038227?

NCT06038227 is sponsored by Intuitive Surgical. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06038227?

The trial aims to enroll 512 participants. The trial is currently recruiting and accepting new participants.

How is NCT06038227 designed?

This is a observational study.

What are the primary outcomes being measured in NCT06038227?

The primary outcome measures are: Patient reported Quality of Life 1 (1 month post surgery); Patient reported Quality of Life 2 (1 month post surgery). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06038227 being conducted?

This trial is being conducted at 12 sites, including Copenhagen; Marseille; Rouen; Toulouse and 8 more sites (Denmark, France, Germany).

Where can I find official information about NCT06038227?

The official record for NCT06038227 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06038227. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06038227 testing in simple terms?

This study compares robotic-assisted surgery with traditional minimally invasive surgery for early-stage lung cancer. It is for patients diagnosed with early-stage non-small cell lung cancer.

Why is this trial significant?

This trial matters because it aims to determine if robotic surgery offers better outcomes than traditional minimally invasive surgery for early lung cancer, potentially improving patient recovery and

What are the potential risks of participating in NCT06038227?

As with any surgery, there are risks of infection, bleeding, and complications related to anesthesia. Specific risks for minimally invasive surgery can include pain, scarring, and potential need to convert to open surgery if complications arise. Robotic surgery may have specific risks related to the equipment and specialized training required. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06038227?

Ask your doctor about the specific type of minimally invasive surgery planned (robotic vs. VATS) and why it's recommended for you. Understand that you will be monitored closely after surgery, including assessments of your quality of life. Be prepared for potential follow-up appointments and questionnaires to track your recovery. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06038227 signal from an investment perspective?

This study, sponsored by Intuitive Surgical (a leader in robotic surgery), investigates the comparative effectiveness of their technology, suggesting a focus on demonstrating the value of robotic-assi This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves undergoing either robotic or traditional minimally invasive surgery and follow-up assessments. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.