RecruitingNCT07057648

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)


Sponsor

Ulsan University Hospital

Enrollment

100 participants

Start Date

Jul 9, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a robotic-assisted bronchoscopy tool — a thin, flexible camera guided by shape-sensing technology — to see how accurately it can diagnose small lung nodules (spots on the lung) without needing open surgery. This is a Korean multicenter study. **You may be eligible if...** - You are 19 years of age or older - You have a solid or partially solid lung nodule found on a CT scan - Your doctor has determined you need a tissue sample (biopsy) from the nodule to confirm a diagnosis - You are otherwise healthy enough to undergo a bronchoscopy procedure **You may NOT be eligible if...** - You have a serious bleeding disorder or are on blood thinners that cannot be stopped - You have severe lung disease that makes bronchoscopy unsafe - You are pregnant - Your nodule is easily accessible by a simpler, standard method Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEShape-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.


Locations(1)

Ulsan University Hospital

Ulsan, South Korea

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NCT07057648


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