A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodul… (NCT06308120) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB
China354 participantsStarted 2024-03-20
Plain-language 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
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able to tolerate bronchoscopy;
. ≥18 years and ≤ 80 years;
. Chest CT scan results suggest one or more pulmonary nodules and suspected pulmonary malignant tumor which requires further diagnostic evaluation\*;
. The pulmonary nodules are solid or part-solid;
. The maximum diameter of the whole nodule is \>8 mm and ≤30 mm;
. 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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Able to understand and adhere to study requirements;
. Able to provide and sign the informed consent form.
Exclusion criteria
. The target nodule has been diagnosed as a malignant tumor or metastatic tumor;
. 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;
. Contraindications to bronchoscopy;
. Contraindication to intubation, general anesthesia, or over American Society of Anesthesiologists (ASA) score of 3;
. Known allergies, sensitivities, or previous allergic reactions to the disinfection reagents for reprocessing of the investigational product;
. Pregnancy;
. Any other condition that may increase the risk of bronchoscopic procedure as identified in the evaluation by the PI or bronchoscopist before bronchoscopic procedure;
. Other conditions that the investigators consider not suitable for the subjects to participate in the study;