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

Not yet recruiting

• Conditions: Lung Nodules; Peripheral Lung Lesions; Pulmonary Nodules; Lung Cancers; Bronchoscopy

• Registration Number: NCT07057648
• Lead Sponsor: Ulsan University Hospital

Brief 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.

Detailed Description

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:

1. Initial airway assessment using conventional flexible bronchoscopy

2. ION system docking to the endotracheal tube

3. Vision probe insertion through the ION catheter (3.5mm outer diameter, 2mm working channel)

4. System registration to align navigation mapping with patient anatomy

5. Catheter navigation to target nodule

6. Vision probe removal and radial EBUS confirmation (when applicable)

7. Tissue sampling using various tools (Flexision biopsy needles, forceps, brush, or cryobiopsy)

8. Fluoroscopic guidance when needed

9. Rapid on-site evaluation (ROSE) when available

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.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-30
• Study First Submitted: 2025-06-30
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Primary Completion: 2026-12-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Yield	At time of procedure and 6 months follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Tissue Sample Adequacy	Within 1 week post-procedure	The proportion of procedures yielding adequate tissue samples for histopathological diagnosis, as determined by the pathologist.
Navigation Success Rate	At time of procedure (Day 0)	The proportion of successful catheter navigation to target nodules using the ION endoluminal system among all attempted procedures.
Radial EBUS Confirmation Rate	At time of procedure (Day 0)	The proportion of target nodules confirmed by radial endobronchial ultrasound (rEBUS) among procedures where rEBUS was attempted.
Rapid On-Site Evaluation (ROSE) Results	At time of procedure (Day 0)	Results of rapid on-site cytological evaluation when performed, including diagnostic adequacy and preliminary findings.
Sensitivity for Malignant Nodules	6 months follow-up	The proportion of malignant nodules correctly identified by ssRAB among all nodules confirmed to be malignant by final diagnosis.
Procedure-related Complications	24 hours post-procedure	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.

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of