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

Launched by INTUITIVE SURGICAL · Mar 6, 2024

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ClinConnect Summary

This clinical trial is studying two different methods for diagnosing lung nodules—specifically, the ION™ Endoluminal System and a technique called electromagnetic navigation bronchoscopy (ENB). The goal is to see which method is better at helping doctors obtain samples from lung nodules that might be cancerous. This trial is currently looking for participants who are between 18 and 80 years old and have been found to have one or more suspicious lung nodules on a chest CT scan. To qualify, participants need to be able to tolerate a bronchoscopy, which is a procedure that lets doctors look inside the lungs, and the nodules must be solid or partly solid, measuring between 8 and 30 millimeters.

If you decide to participate, you can expect to undergo the bronchoscopy procedure using one of the two methods being studied. It's important to note that this trial is only for individuals who have not been diagnosed with lung cancer yet and who meet specific health criteria. Participants will be asked to sign an informed consent form, meaning they understand the study and agree to take part in it. This is a great opportunity to contribute to research that could improve how lung nodules are diagnosed in the future.

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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.