Shape-sensing robotic bronchoscopy to diagnose peripheral lung nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center observational cohort in which shape-sensing robotic-assisted bronchoscopy (ssRAB) replaces conventional bronchoscopy for patients needing tissue diagnosis of peripheral pulmonary nodules. Planning uses thin-section chest CT to create a 3D navigation map, and the ssRAB system uses shape-sensing fiber optics to guide and stabilize the bronchoscopic catheter to the target. Procedures are performed under sedation or general anesthesia with tissue sampling and safety monitoring, and patients are followed for adverse events and diagnostic outcomes for six months. The main focus is on diagnostic yield and safety of ssRAB in a Korean clinical setting.

Why it matters

Who can join: the full rules

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

Where it's running

• Ulsan University Hospital
  Ulsan, South Korea Recruiting

Study contacts

• Principal investigator: Ganghee Chae, MD, PhD — Ulsan University Hospital
• Study coordinator: Ganghee Chae, MD, PhD
• Email: ganghee@uuh.ulsan.kr
• Phone: +82-52-250-8705

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.