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Starting soon Observational

Robotic Bronchoscopy for Small Lung Nodules Without a Bronchus Sign

NCT07862816 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2027-01
Last updated
2026-10-07

Condition(s) studied

Lung Cancer (Diagnosis)

Study summary

The goal of this observational study is to learn about the diagnostic performance and safety of robotic-assisted bronchoscopy using the Ion Endoluminal System in adults with small lung nodules that do not show a bronchus sign on CT imaging.

The main questions it aims to answer are:

* How effective is robotic-assisted bronchoscopy in obtaining a diagnosis for small lung nodules without a bronchus sign?
* How safe is the procedure, including the risk of complications such as pneumothorax and bleeding?

Participants who are already scheduled to undergo lung nodule biopsy using the Ion Endoluminal System and integrated mobile cone-beam CT (mCBCT) as part of their routine clinical care will be enrolled in this study.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient is aged 19 years or older at the time of consent. * Single pulmonary nodule planned for biopsy with the integrated Ion Endoluminal System/mCBCT platform. * Target pulmonary nodule (solid or subsolid) with overall largest diameter ≤20 mm and solid component \>5 mm in largest diameter, measured across axial, sagittal, and coronal CT. * Target pulmonary nodule is bronchus sign negative on thin section CT (≤1 mm). Exclusion Criteria: * Patient is planned for non-surgical oncological treatment (e.g., SBRT, chemotherapy) regardless of biopsy outcome. * Patient with a nodule that is amenable to linear EBUS sampling. * More than one target pulmonary nodule planned for biopsy during the index bronchoscopy procedure. * Patient has a history of pneumonectomy. * Patient is legally incapacitated or in a legal/court-ordered institution or is part of a known vulnerable population, including but not limited to dependency on the Sponsor, Institution, or Investigator. * Patient is not willing or able (as deemed by the Investigator) to comply with study participation requirements. * Investigator, in their professional opinion, has decided that it is in the patient's best interest not to participate in the clinical study. * Patient is pregnant, nursing, or planning to become pregnant.

Primary outcome measure(s)

  • Diagnostic yield assessed using the ATS/ACCP consensus definition. — At completion of index biopsy procedure
    Diagnostic yield will be calculated according to the ATS/ACCP consensus definition using the diagnosis established from the index biopsy procedure.

Trial sites (4)

FacilityCityRegionStatus
National Cancer Center Goyang-si Gyeonggi-do
Chungnam National University Hospital Daejeon South Korea
Samsung Medical Center Seoul South Korea
Ulsan University Hospital Ulsan South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07862816 on ClinicalTrials.gov ↗ ← All trials in South Korea