Comparing robotic-assisted bronchoscopy with electromagnetic navigation for lung nodule diagnosis

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

This study is testing if a new robotic tool for lung exams can find lung nodules more accurately and quickly than the traditional method for people who might have lung cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 354 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Intuitive Surgical (Industry-sponsored)
• Locations: 3 sites (Shanghai, Shanghai and 2 other locations)
• Trial ID: NCT06308120 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of the ION™ Endoluminal System, a robotic-assisted bronchoscopy tool, in diagnosing peripheral lung nodules compared to the traditional electromagnetic navigation bronchoscopy. The study involves a multi-center randomized controlled design where patients with suspected malignant pulmonary nodules will undergo transbronchial sampling procedures. The trial seeks to improve diagnostic accuracy and reduce the time to diagnosis for lung cancer, which is critical given its high mortality rate. By utilizing advanced bronchoscopic techniques, the study hopes to enhance the yield of diagnostic procedures for peripheral lung nodules.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with solid or part-solid pulmonary nodules greater than 8 mm and suspected of being malignant.

Not a fit: Patients who have already been diagnosed with a malignant tumor or have central lesions will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the diagnostic accuracy and speed of lung cancer detection in patients with peripheral nodules.

How similar studies have performed: Other studies have shown promise with advanced bronchoscopic techniques, but the specific use of the ION™ Endoluminal System in this context is relatively novel.

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.

Where this trial is running

Shanghai, Shanghai and 2 other locations

• Shanghai Chest Hospital — Shanghai, Shanghai, China (Recruiting)
• Zhongshan Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
• West China Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Jiayuan Sun, M.D. — Shanghai Chest Hospital
• Study coordinator: Yueping Qian, Ph.D.

Conditions Pulmonary Nodule, Solitary; Lung Cancer