Shape-sensing robotic bronchoscopy to diagnose peripheral lung nodules
Shape-sensing Robotic-assisted Bronchoscopy (ssRAB) for Diagnosis of Peripheral Pulmonary Nodules: A Prospective Cohort Study in Korea (the ULSAN-ION Study)
This tests a shape-sensing robotic bronchoscopy to see if it can get tissue samples from adults in Korea with peripheral lung nodules.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Ulsan University Hospital Academic / other |
| Locations | 1 site (Ulsan) |
| Trial ID | NCT07057648 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center observational cohort in which shape-sensing robotic-assisted bronchoscopy (ssRAB) replaces conventional bronchoscopy for patients needing tissue diagnosis of peripheral pulmonary nodules. Planning uses thin-section chest CT to create a 3D navigation map, and the ssRAB system uses shape-sensing fiber optics to guide and stabilize the bronchoscopic catheter to the target. Procedures are performed under sedation or general anesthesia with tissue sampling and safety monitoring, and patients are followed for adverse events and diagnostic outcomes for six months. The main focus is on diagnostic yield and safety of ssRAB in a Korean clinical setting.
Who should consider this trial
Good fit: Adults aged 19 or older with solid or part-solid peripheral pulmonary nodules who need histologic diagnosis and are fit for bronchoscopy under sedation or general anesthesia (ECOG 0–2) are ideal candidates.
Not a fit: Patients with pure ground-glass nodules, significant bleeding risk, severe cardiopulmonary dysfunction preventing deep sedation, pregnancy, or life expectancy under six months are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, ssRAB could increase the chance of getting a definitive tissue diagnosis from bronchoscopy and reduce the need for riskier procedures.
How similar studies have performed: International studies of the same ssRAB system have reported diagnostic yields around 87–90% with favorable safety profiles, suggesting promising results outside Korea.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ulsan
- Ulsan University Hospital — Ulsan, South Korea (Recruiting)
Study contacts
- Principal investigator: Ganghee Chae, MD, PhD — Ulsan University Hospital
- Study coordinator: Ganghee Chae, MD, PhD
- Email: ganghee@uuh.ulsan.kr
- Phone: +82-52-250-8705
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.