NCT07057648Recruiting
Shape-Sensing Robotic-Assisted Bronchoscopy for Diagnosis of Peripheral Pulmonary Nodules in Korea
Shape-sensing Robotic-assisted Bronchoscopy (ssRAB) for Diagnosis of Peripheral Pulmonary Nodules: A Prospective Cohort Study in Korea (the ULSAN-ION Study)
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 30 Jun 2025
- Start date
- 9 Jul 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Ulsan University Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07057648
What you commit to
- Study type: Observational
- Planned participants: 100
- From 9 Jul 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Bleeding tendency defined as platelet count less than 50,000/μL or International Normalized Ratio (INR) greater than 1.5
Other
- Pure ground glass opacity nodules
- 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
- Participation in another interventional clinical trial that may interfere with study procedures or outcomes
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.