NCT07057648 Shape-Sensing Robotic-Assisted Bronchoscopy for Diagnosis of Peripheral Pulmonary Nodules in Korea
| NCT ID | NCT07057648 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ulsan University Hospital |
| Condition | Lung Nodules |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-09 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-07-09 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Ganghee Chae, MD, PhD
PRINCIPAL INVESTIGATOR
Ulsan University Hospital
Frequently Asked Questions
Who can join the NCT07057648 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Lung Nodules. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07057648 currently recruiting?
Yes, NCT07057648 is actively recruiting participants. Contact the research team at ganghee@uuh.ulsan.kr for enrollment information.
Where is the NCT07057648 trial being conducted?
This trial is being conducted at Ulsan, South Korea.
Who is sponsoring the NCT07057648 clinical trial?
NCT07057648 is sponsored by Ulsan University Hospital. The principal investigator is Ganghee Chae, MD, PhD at Ulsan University Hospital. The trial plans to enroll 100 participants.