NCT07862816Not yet recruiting
Robotic Bronchoscopy for Small Lung Nodules Without a Bronchus Sign
ROBISN: Shape-sensing Robotic-assisted Bronchoscopy for Investigation of Small, Bronchus Sign Absent Nodules
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 151 (estimated)
- First submitted
- 2 Oct 2026
- Start date
- Jan 2027
- Primary completion date
- Nov 2028
- Lead sponsor
- Intuitive Surgical
- Diseases
- Lung cancer
- NCT number
- NCT07862816
What you commit to
- Study type: Observational
- Planned participants: 151
- From Jan 2027 to the primary completion date, Nov 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient is planned for non-surgical oncological treatment (e.g., SBRT, chemotherapy) regardless of biopsy outcome.
Other illness
- Patient has a history of pneumonectomy.
Other
- 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 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.
Who the study is looking for
- 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).
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.