A Randomized Controlled Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB

Robotic Bronchoscopy vs. Standard for Lung Nodules

NCT: NCT06308120 · Status: ACTIVE NOT RECRUITING · Phase: N/A · Sponsor: Intuitive Surgical · Started: 2024-03-20 · Est. Completion: 2027-01-30

Plain English Summary

A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB is a Not Applicable clinical trial sponsored by Intuitive Surgical studying Pulmonary Nodule, Solitary, Lung Cancer. This trial compares a robotic-assisted bronchoscopy system (ION) to a standard navigation system for diagnosing lung nodules. It is for adults aged 18-80 with suspected lung cancer nodules that need further testing. Participation involves a bronchoscopy procedure where doctors use either the robotic system or the standard system to take tissue samples. Alternatives include other biopsy methods or waiting for more information from imaging. The trial aims to enroll 354 participants.

Official Summary

Multi-center randomized controlled study designed to compare the diagnostic yield of ION™ Endoluminal System with electromagnetic navigation bronchoscopy in patients undergoing transbronchial sampling procedure of peripheral pulmonary nodules.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 80 years old and have a lung nodule that might be cancerous. You cannot join if the nodule is already diagnosed as cancer, is very close to the main airways, or if you have serious health issues that make bronchoscopy risky. You must be able to undergo a bronchoscopy and general anesthesia, and understand and follow study instructions. This trial is studying Pulmonary Nodule, Solitary, Lung Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how often each method successfully obtains a tissue sample that can be used to diagnose the lung nodule. The specific primary outcome measures are: Diagnostic Yield (6 months post-procedure). 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 improve the accuracy and effectiveness of diagnosing lung nodules, potentially leading to earlier cancer detection and better patient outcomes. This research targets Pulmonary Nodule, Solitary, Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial signals a growing market for advanced diagnostic tools in pulmonology, with Intuitive Surgical investing in robotic-assisted procedures to improve diagnostic capabilities and potentially ca

Is This Trial Right for Me?

Ask your doctor about the risks and benefits of both robotic-assisted and standard bronchoscopy. Understand that you will undergo a procedure where a thin tube is inserted into your lungs to take a sample. You will need to follow post-procedure instructions and attend follow-up appointments. The trial is being conducted at 3 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:

1. Able to tolerate bronchoscopy;
2. ≥18 years and ≤ 80 years;
3. Chest CT scan results suggest one or more pulmonary nodules and suspected pulmonary malignant tumor which requires further diagnostic evaluation\*;
4. The pulmonary nodules are solid or part-solid;
5. The maximum diameter of the whole nodule is \>8 mm and ≤30 mm;
6. Chest CT scan results suggest peripheral nodules which are defined as nodules in the Generation 4 or above of the airway (trachea is defined as Generation 0, left and right principal bronchi as Generation 1, lobar bronchi as Generation 2, segmental bronchi as Generation 3, and subsegmental bronchi as Generation 4);
7. Able to understand and adhere to study requirements;
8. Able to provide and sign the informed consent form.

Exclusion Criteria:

1. The target nodule has been diagnosed as a malignant tumor or metastatic tumor;
2. The target nodule is later determined as a central lesion (the target nodule is in the airway, and not at a subsegmental or more distal location) during the bronchoscopy before the study procedure starts;
3. Contraindications to bronchoscopy;
4. Contraindication to intubation, general anesthesia, or over American Society of Anesthesiologists (ASA) score of 3;
5. Known allergies, sensitivities, or previous allergic reactions to the disinfection reagents for reprocessing of the investigational product;
6. Pregnancy;
7. Any other condition that may increase the risk of bronchoscopic procedure as identified in the evaluation by the PI or bronchoscopist before bronchoscopic procedure;
8. Other conditions that the investigators consider not suitable for the subjects to participate in the study;
9. Participation in any other interventional or investigational clinical studies within 30 days before enrollment.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06308120?

NCT06308120 is a Not Applicable INTERVENTIONAL study titled "A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB." It is currently active, not recruiting and is sponsored by Intuitive Surgical. The trial targets enrollment of 354 participants.

What conditions does NCT06308120 study?

This trial investigates treatments for Pulmonary Nodule, Solitary, Lung Cancer. The primary condition under study is Pulmonary Nodule, Solitary.

What treatments are being tested in NCT06308120?

The interventions being studied include: Ion Endoluminal System (DEVICE), superDimension Navigation System and Accessories (DEVICE). Participants in the test arm will undergo a diagnostic bronchoscopy with ION™ Endoluminal System.

What does Not Applicable mean for NCT06308120?

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 NCT06308120?

This trial is currently "Active, Not Recruiting." It started on 2024-03-20. The estimated completion date is 2027-01-30.

Who is sponsoring NCT06308120?

NCT06308120 is sponsored by Intuitive Surgical. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06308120?

The trial aims to enroll 354 participants. The trial status is active, not recruiting.

How is NCT06308120 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT06308120?

The primary outcome measures are: Diagnostic Yield (6 months post-procedure). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06308120 being conducted?

This trial is being conducted at 3 sites, including Shanghai, Shanghai Municipality; Chengdu, Sichuan (China).

Where can I find official information about NCT06308120?

The official record for NCT06308120 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06308120. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06308120 testing in simple terms?

This trial compares a robotic-assisted bronchoscopy system (ION) to a standard navigation system for diagnosing lung nodules. It is for adults aged 18-80 with suspected lung cancer nodules that need further testing.

Why is this trial significant?

This trial matters because it aims to improve the accuracy and effectiveness of diagnosing lung nodules, potentially leading to earlier cancer detection and better patient outcomes.

What are the potential risks of participating in NCT06308120?

Potential risks include bleeding, pneumothorax (collapsed lung), and reactions to anesthesia or cleaning solutions. Some patients may experience discomfort or pain after the procedure. There's a possibility that the sample taken may not be sufficient for diagnosis, requiring further procedures. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06308120?

Ask your doctor about the risks and benefits of both robotic-assisted and standard bronchoscopy. Understand that you will undergo a procedure where a thin tube is inserted into your lungs to take a sample. You will need to follow post-procedure instructions and attend follow-up appointments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06308120 signal from an investment perspective?

This trial signals a growing market for advanced diagnostic tools in pulmonology, with Intuitive Surgical investing in robotic-assisted procedures to improve diagnostic capabilities and potentially ca 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 a bronchoscopy procedure where doctors use either the robotic system or the standard system to take tissue samples. 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.

Related Conditions

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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.