An observational study in Lung Nodules, Peripheral Lung Lesions and Pulmonary Nodules, sponsored by Ulsan University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Ulsan University Hospital · Observational
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.
Background and Rationale:
Peripheral pulmonary nodules (PPNs) are increasingly detected due to widespread use of computed tomography (CT) imaging and lung cancer screening programs. Current bronchoscopic diagnostic methods, including electromagnetic navigation bronchoscopy (ENB) and radial endobronchial ultrasound (rEBUS), have diagnostic yields of approximately 70%, with lower success rates for smaller nodules (\<20mm), nodules in the outer third of the lung, and those without bronchus sign.
The ION endoluminal system (Intuitive Surgical, Sunnyvale, CA) represents a novel approach using shape-sensing robotic-assisted bronchoscopy (ssRAB) technology. This system employs shape-sensing fiber optics throughout the catheter length to provide real-time catheter position and orientation monitoring, enabling precise navigation and stable positioning capabilities. International studies have reported diagnostic yields of 87-90% with favorable safety profiles.
Study Design and Methodology:
This is a prospective, single-center, observational cohort study designed to evaluate the diagnostic performance and safety of ssRAB in Korean patients. The study will be conducted as part of routine clinical care, with ssRAB replacing conventional bronchoscopy for eligible patients requiring histological diagnosis of peripheral lung nodules.
Pre-procedure Planning:
All participants will undergo thin-section chest CT (≤1.25mm thickness) for 3D navigation planning using PlanPoint Planning Laptop software. Target nodule characteristics, approach pathways, and procedure strategy will be determined prior to the procedure.
Procedure Protocol:
The ssRAB procedure will be performed under deep sedation or general anesthesia using an 8.0mm or larger endotracheal tube. The procedure involves:
Safety Monitoring:
All procedure-related complications will be documented according to CTCAE v5.0 criteria. Post-procedure monitoring includes chest imaging to assess for pneumothorax and clinical observation for bleeding, infection, or other adverse events. Participants will be followed for 24 hours post-procedure for immediate complications.
Follow-up and Diagnosis Confirmation:
Participants will be followed for 6 months to establish final diagnosis. For non-specific benign findings, final diagnosis will be confirmed through additional procedures (surgery or CT-guided biopsy) or 6-month follow-up imaging showing nodule improvement or resolution.
Statistical Analysis:
The primary endpoint is diagnostic yield, defined as the proportion of lesions with definitive diagnosis among total sampled lesions. Secondary endpoints include navigation success rate, rEBUS confirmation rate, procedural performance metrics (registration time, navigation time, total procedure time, fluoroscopy time), and safety outcomes. Based on previous studies reporting 87.8% diagnostic yield, a sample size of 100 patients provides adequate power with 95% confidence interval and ±7% margin of error, accounting for 10% dropout rate.
Expected Impact:
This study will provide the first Korean data on ssRAB performance and safety, potentially establishing evidence for broader implementation of this technology in Korea. The results may contribute to improved diagnostic accuracy for peripheral lung nodules and better patient outcomes through earlier and more accurate diagnosis of lung cancer.
99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.
This study's planned enrollment of 100 is below the median of 255 across 51 observational studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →Ulsan University Hospital is the lead sponsor of 28 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with peripheral pulmonary nodules detected on chest CT imaging who require tissue sampling for histological diagnosis. Participants will be recruited from patients referred to the pulmonology department for evaluation of lung nodules. The study population includes patients with solid or part-solid nodules suspicious for malignancy or requiring tissue confirmation for clinical management decisions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Absolute to bronchoscopy including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with peripheral lung nodules who undergo shape-sensing robotic-assisted bronchoscopy (ssRAB) for tissue sampling and diagnosis. All participants receive the same procedure using the ION endoluminal system to navigate to peripheral lung nodules and obtain tissue samples for histological diagnosis.
Device: Shape-sensing Robotic-assisted Bronchoscopy (ssRAB)
Diagnostic procedure using the ION endoluminal system (Intuitive Surgical, Sunnyvale, CA) for navigation and tissue sampling of peripheral pulmonary nodules. The procedure involves: 1. Pre-procedure 3D navigation planning using thin-section chest CT 2. Shape-sensing catheter navigation to target nodules 3. Real-time position monitoring with fiber optic sensors 4. Tissue sampling using various tools (biopsy needles, forceps, brush, or cryobiopsy) 5. Optional radial endobronchial ultrasound (rEBUS) confirmation 6. Fluoroscopic guidance when needed The procedure is performed under deep sedation or general anesthesia through an endotracheal tube.
Diagnostic Yield (Proportion of lesions with definitive diagnosis)
The proportion of lesions with definitive diagnosis among total biopsied lesions using shape-sensing robotic-assisted bronchoscopy (ssRAB). Diagnostic results are defined as malignant findings, specific benign findings (e.g., tuberculosis, hamartoma), or non-specific benign findings confirmed by additional procedures or 6-month follow-up imaging showing nodule improvement or resolution.
Time frame: At time of procedure and 6 months follow-up
Navigation Success Rate
The proportion of successful catheter navigation to target nodules using the ION endoluminal system among all attempted procedures.
Time frame: At time of procedure (Day 0)
Radial EBUS Confirmation Rate
The proportion of target nodules confirmed by radial endobronchial ultrasound (rEBUS) among procedures where rEBUS was attempted.
Time frame: At time of procedure (Day 0)
Sensitivity for Malignant Nodules
The proportion of malignant nodules correctly identified by ssRAB among all nodules confirmed to be malignant by final diagnosis.
Time frame: 6 months follow-up
Incidence of Procedure-related Complications
Incidence of procedure-related complications including pneumothorax, bleeding (\>50mL), infection, and other adverse events. Complications will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: 24 hours post-procedure
Tissue Sample Adequacy (Proportion of procedures yielding adequate tissue samples)
The proportion of procedures yielding adequate tissue samples for histopathological diagnosis, as determined by the pathologist.
Time frame: Within 1 week post-procedure
Proportion of procedures with adequate Rapid On-Site Evaluation (ROSE) Results
Results of rapid on-site cytological evaluation when performed, including diagnostic adequacy and preliminary findings.
Time frame: At time of procedure (Day 0)
Plan to share: No
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Ulsan University Hospital