Actively Recruiting
Shape-Sensing Robotic-Assisted Bronchoscopy for Diagnosis of Peripheral Pulmonary Nodules in Korea
Led by Ulsan University Hospital · Updated on 2026-02-13
100
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
What is this study about? This study tests a new robotic technology to take tissue samples from lung nodules (small spots in the lungs). Some lung nodules are cancer, but doctors need a tissue sample to know for sure. What is the problem? Current methods to get tissue from lung nodules only work about 7 out of 10 times. When they don't work, doctors may need riskier procedures. What is the new technology? The new technology is called robotic bronchoscopy (ssRAB). It uses a robot with special sensors to guide a thin tube more accurately to lung nodules than current methods. Who can join? Adults aged 19 or older who have lung nodules that need tissue sampling and are healthy enough for the procedure. What happens? Participants will have the robotic procedure while asleep under anesthesia. The robot guides a thin tube to the lung nodule to take a small tissue sample. Participants are watched for problems and followed for 6 months. What are the risks and benefits? The new technology may be more accurate and safer than current methods. The main risks are small chance of lung collapse or bleeding, similar to regular procedures. Why is this important? This study will show if the new robotic technology works well and is safe in Korea. If successful, it could help diagnose lung cancer earlier and more accurately. This study will include 100 people at Ulsan University Hospital in Korea.
CONDITIONS
Official Title
Shape-Sensing Robotic-Assisted Bronchoscopy for Diagnosis of Peripheral Pulmonary Nodules in Korea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ulsan University Hospital
Ulsan, South Korea, 44033
Actively Recruiting
Research Team
G
Ganghee Chae, MD, PhD
CONTACT
T
Taehoon Lee, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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