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

Summary

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.

Eligibility

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

Conditions7

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