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Shape-Sensing Robotic-Assisted Bronchoscopy for Diagnosis of Peripheral Pulmonary Nodules in Korea

NCT07057648 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

  • Lung Nodules
  • Peripheral Lung Lesions
  • Pulmonary Nodules
  • Lung Cancers
  • Bronchoscopy

Interventions

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.

Sponsors & Collaborators

  • Ulsan University Hospital

    lead OTHER

Principal Investigators

  • Ganghee Chae, MD, PhD · Ulsan University Hospital

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-09
Primary Completion
2026-12-31
Completion
2027-05-31
FDA Device
Yes

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07057648 on ClinicalTrials.gov