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

NCT07057648 | Recruiting FDA Device

• 1 other identifier: 2025-06-002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Lung Lesions; Pulmonary Nodules; Lung Cancers; Bronchoscopy; Lung Nodules

Keywords

Shape-sensing robotic-assisted bronchoscopy; ssRAB; Robotic bronchoscopy; Peripheral lung nodules; Diagnostic yield; Lung Nodules; Navigation bronchoscopy; Lung biopsy; Korea; Prospective cohort

Outcome Measures

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.

  At time of procedure and 6 months follow-up

Secondary Outcomes (6)

• Navigation Success Rate

  At time of procedure (Day 0)

• Radial EBUS Confirmation Rate

  At time of procedure (Day 0)

• Sensitivity for Malignant Nodules

  6 months follow-up

• Incidence of Procedure-related Complications

  24 hours post-procedure

• Tissue Sample Adequacy (Proportion of procedures yielding adequate tissue samples)

  Within 1 week post-procedure

Study Arms (1)

ssRAB Cohort

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)

Interventions

Shape-sensing Robotic-assisted Bronchoscopy (ssRAB) DEVICE

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.

ssRAB Cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ulsan University Hospital: lead

Study Sites (1)

Ulsan University Hospital

Ulsan, 44033, South Korea

RECRUITING

Related Publications (11)

• Xie F, Zhang Q, Mu C, Zhang Q, Yang H, Mao J, Simoff MJ, Huang J, Zhang X, Sun J. Shape-sensing Robotic-assisted Bronchoscopy (SS-RAB) in Sampling Peripheral Pulmonary Nodules: A Prospective, Multicenter Clinical Feasibility Study in China. J Bronchology Interv Pulmonol. 2024 Aug 8;31(4):e0981. doi: 10.1097/LBR.0000000000000981. eCollection 2024 Oct 1.

  PMID: 39115240 RESULT

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 RESULT

• Reisenauer J, Simoff MJ, Pritchett MA, Ost DE, Majid A, Keyes C, Casal RF, Parikh MS, Diaz-Mendoza J, Fernandez-Bussy S, Folch EE. Ion: Technology and Techniques for Shape-sensing Robotic-assisted Bronchoscopy. Ann Thorac Surg. 2022 Jan;113(1):308-315. doi: 10.1016/j.athoracsur.2021.06.086. Epub 2021 Aug 8.

  PMID: 34370981 RESULT

• Ost DE, Ernst A, Lei X, Kovitz KL, Benzaquen S, Diaz-Mendoza J, Greenhill S, Toth J, Feller-Kopman D, Puchalski J, Baram D, Karunakara R, Jimenez CA, Filner JJ, Morice RC, Eapen GA, Michaud GC, Estrada-Y-Martin RM, Rafeq S, Grosu HB, Ray C, Gilbert CR, Yarmus LB, Simoff M; AQuIRE Bronchoscopy Registry. Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the AQuIRE Registry. Am J Respir Crit Care Med. 2016 Jan 1;193(1):68-77. doi: 10.1164/rccm.201507-1332OC.

  PMID: 26367186 RESULT

• Nadig TR, Thomas N, Nietert PJ, Lozier J, Tanner NT, Wang Memoli JS, Pastis NJ, Silvestri GA. Guided Bronchoscopy for the Evaluation of Pulmonary Lesions: An Updated Meta-analysis. Chest. 2023 Jun;163(6):1589-1598. doi: 10.1016/j.chest.2022.12.044. Epub 2023 Jan 11.

  PMID: 36640994 RESULT

• MacMahon H, Naidich DP, Goo JM, Lee KS, Leung ANC, Mayo JR, Mehta AC, Ohno Y, Powell CA, Prokop M, Rubin GD, Schaefer-Prokop CM, Travis WD, Van Schil PE, Bankier AA. Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images: From the Fleischner Society 2017. Radiology. 2017 Jul;284(1):228-243. doi: 10.1148/radiol.2017161659. Epub 2017 Feb 23.

  PMID: 28240562 RESULT

• Kang MJ, Won YJ, Lee JJ, Jung KW, Kim HJ, Kong HJ, Im JS, Seo HG; Community of Population-Based Regional Cancer Registries. Cancer Statistics in Korea: Incidence, Mortality, Survival, and Prevalence in 2019. Cancer Res Treat. 2022 Apr;54(2):330-344. doi: 10.4143/crt.2022.128. Epub 2022 Mar 16.

  PMID: 35313102 RESULT

• Gould MK, Tang T, Liu IL, Lee J, Zheng C, Danforth KN, Kosco AE, Di Fiore JL, Suh DE. Recent Trends in the Identification of Incidental Pulmonary Nodules. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1208-14. doi: 10.1164/rccm.201505-0990OC.

  PMID: 26214244 RESULT

• Folch EE, Labarca G, Ospina-Delgado D, Kheir F, Majid A, Khandhar SJ, Mehta HJ, Jantz MA, Fernandez-Bussy S. Sensitivity and Safety of Electromagnetic Navigation Bronchoscopy for Lung Cancer Diagnosis: Systematic Review and Meta-analysis. Chest. 2020 Oct;158(4):1753-1769. doi: 10.1016/j.chest.2020.05.534. Epub 2020 May 23.

  PMID: 32450240 RESULT

• Benn BS, Romero AO, Lum M, Krishna G. Robotic-Assisted Navigation Bronchoscopy as a Paradigm Shift in Peripheral Lung Access. Lung. 2021 Apr;199(2):177-186. doi: 10.1007/s00408-021-00421-1. Epub 2021 Feb 6.

  PMID: 33547938 RESULT

• Ali MS, Sethi J, Taneja A, Musani A, Maldonado F. Computed Tomography Bronchus Sign and the Diagnostic Yield of Guided Bronchoscopy for Peripheral Pulmonary Lesions. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2018 Aug;15(8):978-987. doi: 10.1513/AnnalsATS.201711-856OC.

  PMID: 29877715 RESULT

MeSH Terms

Conditions

Multiple Pulmonary Nodules; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ganghee Chae, MD, PhD

  Ulsan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ganghee Chae, MD, PhD

CONTACT

+82-52-250-8705; ganghee@uuh.ulsan.kr

Taehoon Lee, MD, PhD

CONTACT

+82-52-250-8705; tleepulalg@uuh.ulsan.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: July 9, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)