Shape-Sensing Robotic-Assisted Bronchoscopy for Diagnosis of Peripheral Pulmonary Nodules in Korea

Launched by ULSAN UNIVERSITY HOSPITAL · Jun 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new robotic technology to help doctors take small tissue samples from lung nodules, which are tiny spots found in the lungs. Sometimes these nodules can be cancer, but doctors need a sample to know for sure. The usual methods to get these samples work about 70% of the time, and when they don’t, patients might need more risky procedures. This new technology uses a robot with special sensors to guide a thin tube more precisely to the lung nodule, which may improve accuracy and safety.

Adults aged 19 or older who have lung nodules seen on a CT scan and need a tissue sample may be able to join, as long as they are healthy enough for the procedure. During the study, participants will have the robotic procedure while asleep under anesthesia. The robot will help guide a thin tube to the nodule to collect a small sample. Afterward, participants will be monitored for any problems and followed for six months. The main risks are similar to current procedures, like a small chance of lung collapse or bleeding. This study, taking place at Ulsan University Hospital in Korea with 100 participants, aims to see if this robotic method works well and is safe, potentially helping doctors diagnose lung cancer earlier and more accurately.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged 19 years or older
• • Solid or part-solid peripheral pulmonary nodules confirmed on chest computed tomography (CT)
• • Patients requiring histological diagnosis as determined by the treating physician
• • Patients eligible for bronchoscopy procedure
• • Ability to provide written informed consent
• • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or equivalent functional status allowing procedure under sedation or general anesthesia
• Exclusion Criteria:
• • Pure ground glass opacity nodules
• • Bleeding tendency defined as platelet count less than 50,000/μL or International Normalized Ratio (INR) greater than 1.5
• • Severe cardiopulmonary dysfunction precluding deep sedation or general anesthesia
• • Pregnant or breastfeeding women
• • Life expectancy less than 6 months as assessed by the treating physician
• • Inability or unwillingness to provide informed consent
• * Absolute contraindication to bronchoscopy including:
• • Severe hypoxemia (oxygen saturation \<90% on room air)
• • Severe pulmonary hypertension
• • Recent myocardial infarction (within 6 weeks)
• • Unstable angina
• • Malignant arrhythmias
• • Participation in another interventional clinical trial that may interfere with study procedures or outcomes