Lung Cancer (Diagnosis)NCT07862816
Robotic Bronchoscopy for Small Lung Nodules Without a Bronchus Sign
An observational study of Lung Cancer (Diagnosis), run by Intuitive Surgical at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis)
- How many people
- 151 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Jan 2027to Mar 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults planned to undergo a pulmonary nodule biopsy using the Ion Endoluminal System and integrated mobile cone beam CT (mCBCT)
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chunsik Eum contact
South Korea4 sites
Chungnam National University Hospital
Daejeon, 35015
Dongil Park, MD, PhD
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Bin Hwangbo, MD, PhD
Samsung Medical Center
Seoul, 06351
KyungJong Lee, MD, PhD
Ulsan University Hospital
Ulsan, 44033
Ganghee Chae, MD, PhD
About this study
Official title: ROBISN: Shape-sensing Robotic-assisted Bronchoscopy for Investigation of Small, Bronchus Sign Absent Nodules
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:
Read more
- 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.
Read the detailed description
Lung cancer remains a leading cause of cancer-related mortality worldwide, and delayed diagnosis is an important contributor to poor clinical outcomes. Earlier and more accurate diagnosis of small peripheral pulmonary nodules may facilitate timely clinical decision-making and treatment.
The Ion Endoluminal System is a robotic-assisted bronchoscopy platform designed to provide access to peripheral pulmonary lesions. When integrated with mobile cone-beam computed tomography (mCBCT), the system may provide additional imaging information to support localization of small pulmonary nodules during bronchoscopic biopsy. However, prospective clinical data on the diagnostic performance of this integrated approach in small, bronchus sign-negative pulmonary nodules remain limited.
ROBISN is a prospective, multicenter, observational study designed to evaluate the clinical performance of bronchoscopic biopsy using the integrated Ion Endoluminal System and mCBCT platform in patients with small peripheral pulmonary nodules that are considered challenging for conventional bronchoscopic biopsy.
The study will enroll adult patients who are already clinically planned to undergo bronchoscopic biopsy using the Ion Endoluminal System and mCBCT as part of their routine clinical care. Eligible patients will have a single target pulmonary nodule with a maximum diameter of 20 mm or less, measured on axial, sagittal, and coronal computed tomography images. The target nodule must also be bronchus sign-negative on thin-section computed tomography.
This is an observational study, and participation in the study will not determine the patient's clinical diagnostic or treatment pathway. All bronchoscopic procedures, imaging, biopsy techniques, pathology assessments, subsequent diagnostic evaluations, and treatment decisions will be performed according to the participating institution's standard clinical practice and the treating physician's judgment.
The study will prospectively collect information related to patient and target lesion characteristics, procedural details, use of adjunctive imaging and biopsy modalities, biopsy results, pathology findings, procedure-related adverse events, and subsequent clinical information used to establish the final diagnosis of the target pulmonary nodule.
Diagnostic outcomes will be assessed using information obtained from the index bronchoscopic biopsy together with subsequent pathology, imaging, clinical follow-up, or other diagnostic procedures, as applicable. Follow-up information will be collected prospectively to evaluate the diagnostic outcome of cases in which the initial biopsy result is not immediately definitive and to characterize the clinical course of the target lesion over time.
Safety outcomes will include clinically relevant procedure-related adverse events, including events such as pneumothorax and bleeding. Other procedural and clinical variables will also be collected to characterize the performance of the integrated Ion Endoluminal System and mCBCT approach in this patient population.
The results of this study are intended to provide prospective, multicenter evidence regarding the use of robotic-assisted bronchoscopy combined with mCBCT for the biopsy of small, bronchus sign-negative pulmonary nodules and to better characterize its diagnostic performance and safety in routine clinical practice.
- Conditions
- Lung Cancer (Diagnosis)
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Ion Robotic Bronchoscopy With mCBCT | Adult patients with a single small, bronchus sign-negative pulmonary nodule who are clinically planned to undergo bronchoscopic biopsy using the integrated Ion Endoluminal System and mobile cone-beam computed tomography (mCBCT) platform as part of routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield assessed using the ATS/ACCP consensus definition.
Diagnostic yield will be calculated according to the ATS/ACCP consensus definition using the diagnosis established from the index biopsy procedure.
Measured: At completion of index biopsy procedure
Secondary outcomes (7)
Intermediate diagnostic yield
Measured: Through establishment of final diagnosis (up to 12 months)
Sensitivity for malignancy
Measured: Through establishment of final diagnosis (up to 12 months)
Rate of pneumothorax (with and without intervention or hospitalization)
Measured: within 7 days post procedure.
Rate of intra-procedure airway bleeding graded using the Nashville Bleeding Scale
Measured: Procedure day
Procedure time (ssRAB catheter in or out)
Measured: During the index biopsy procedure.
Total radiation dose
Measured: During the index biopsy procedure.
Number of cone beam CT (CBCT) spins
Measured: During the index biopsy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862816
- Sponsor's protocol ID
- ISI-ION-KR01
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROBISN: Shape-sensing Robotic-assisted Bronchoscopy for Investigation of Small, Bronchus Sign Absent Nodules
- ClinicalTrials.gov ID
- NCT07862816
- Acronym / sponsor ID
- ISI-ION-KR01
- Conditions
- Lung Cancer (Diagnosis)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lung cancer remains a leading cause of cancer-related mortality worldwide, and delayed diagnosis is an important contributor to poor clinical outcomes. Earlier and more accurate diagnosis of small peripheral pulmonary nodules may facilitate timely clinical decision-making and treatment.
The Ion Endoluminal System is a robotic-assisted bronchoscopy platform designed to provide access to peripheral pulmonary lesions. When integrated with mobile cone-beam computed tomography (mCBCT), the system may provide additional imaging information to support localization of small pulmonary nodules during bronchoscopic biopsy. However, prospective clinical data on the diagnostic performance of this integrated approach in small, bronchus sign-negative pulmonary nodules remain limited.
ROBISN is a prospective, multicenter, observational study designed to evaluate the clinical performance of bronchoscopic biopsy using the integrated Ion Endoluminal System and mCBCT platform in patients with small peripheral pulmonary nodules that are considered challenging for conventional bronchoscopic biopsy.
The study will enroll adult patients who are already clinically planned to undergo bronchoscopic biopsy using the Ion Endoluminal System and mCBCT as part of their routine clinical care. Eligible patients will have a single target pulmonary nodule with a maximum diameter of 20 mm or less, measured on axial, sagittal, and coronal computed tomography images. The target nodule must also be bronchus sign-negative on thin-section computed tomography.
This is an observational study, and participation in the study will not determine the patient's clinical diagnostic or treatment pathway. All bronchoscopic procedures, imaging, biopsy techniques, pathology assessments, subsequent diagnostic evaluations, and treatment decisions will be performed according to the participating institution's standard clinical practice and the treating physician's judgment.
The study will prospectively collect information related to patient and target lesion characteristics, procedural details, use of adjunctive imaging and biopsy modalities, biopsy results, pathology findings, procedure-related adverse events, and subsequent clinical information used to establish the final diagnosis of the target pulmonary nodule.
Diagnostic outcomes will be assessed using information obtained from the index bronchoscopic biopsy together with subsequent pathology, imaging, clinical follow-up, or other diagnostic procedures, as applicable. Follow-up information will be collected prospectively to evaluate the diagnostic outcome of cases in which the initial biopsy result is not immediately definitive and to characterize the clinical course of the target lesion over time.
Safety outcomes will include clinically relevant procedure-related adverse events, including events such as pneumothorax and bleeding. Other procedural and clinical variables will also be collected to characterize the performance of the integrated Ion Endoluminal System and mCBCT approach in this patient population.
The results of this study are intended to provide prospective, multicenter evidence regarding the use of robotic-assisted bronchoscopy combined with mCBCT for the biopsy of small, bronchus sign-negative pulmonary nodules and to better characterize its diagnostic performance and safety in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Ion Robotic Bronchoscopy With mCBCT | – | –Adult patients with a single small, bronchus sign-negative pulmonary nodule who are clinically planned to undergo bronchoscopic biopsy using the integrated Ion Endoluminal System and mobile cone-beam computed tomography (mCBCT) platform as part of routine clinical care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults planned to undergo a pulmonary nodule biopsy using the Ion Endoluminal System and integrated mobile cone beam CT (mCBCT)
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic yield assessed using the ATS/ACCP consensus definition.
Time frame: 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.
7 secondary outcomes
Intermediate diagnostic yield
Time frame: Through establishment of final diagnosis (up to 12 months)
Sensitivity for malignancy
Time frame: Through establishment of final diagnosis (up to 12 months)
Rate of pneumothorax (with and without intervention or hospitalization)
Time frame: within 7 days post procedure.
Rate of intra-procedure airway bleeding graded using the Nashville Bleeding Scale
Time frame: Procedure day
Procedure time (ssRAB catheter in or out)
Time frame: During the index biopsy procedure.
Total radiation dose
Time frame: During the index biopsy procedure.
Number of cone beam CT (CBCT) spins
Time frame: During the index biopsy procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chunsik Eum contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (Diagnosis), run by Intuitive Surgical at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changmin Oh (+82-2-3271-3200 ext. 3253, changmin.oh@intusurg.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield assessed using the ATS/ACCP consensus definition. (time frame: At completion of index biopsy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.