Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bronchoscopy | — | UNRESOLVED | — |
| Lung Cancers | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Nodules | — | UNRESOLVED | — |
| Peripheral Lung Lesions | — | UNRESOLVED | — |
| Pulmonary Nodules | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Shape-sensing Robotic-assisted Bronchoscopy (ssRAB) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ssRAB Cohort
- description
- 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.
- interventionNames
- Device: Shape-sensing Robotic-assisted Bronchoscopy (ssRAB)
Primary outcomes (1)
- measure
- Diagnostic Yield (Proportion of lesions with definitive diagnosis)
- timeFrame
- At time of procedure and 6 months follow-up
- description
- 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 outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (11)
- RESULTXie 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
- RESULTSung 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
- RESULTReisenauer 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
- RESULTOst 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
- RESULTNadig 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
- RESULTMacMahon 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.