Shape-Sensing Robotic-Assisted Bronchoscopy for Diagnosis of Peripheral Pulmonary Nodules in Korea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorUlsan University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Shape-sensing Robotic-assisted Bronchoscopy (ssRAB)
DeviceDiagnostic 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: ssRAB Cohort1 intervention
Trial outcomes
Primary outcomes
1
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-upSecondary outcomes
1
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)2
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)3
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-up4
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-procedureSponsors and contacts
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Source ClinicalTrials.gov