Robotic Bronchoscopy for Small Lung Nodules Without a Bronchus Sign
ConditionLung Cancer (Diagnosis)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorIntuitive Surgical
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
Adults planned to undergo a pulmonary nodule biopsy using the Ion Endoluminal System and integrated mobile cone beam CT (mCBCT)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
151 Participants
are grouped into 1 trial groupGroup A: Patients Undergoing Ion Robotic Bronchoscopy With mCBCT
Trial outcomes
Primary outcomes
1
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.
Time frame
At completion of index biopsy procedureSecondary outcomes
1
Intermediate diagnostic yield
Time frame
Through establishment of final diagnosis (up to 12 months)2
Sensitivity for malignancy
Time frame
Through establishment of final diagnosis (up to 12 months)3
Rate of pneumothorax (with and without intervention or hospitalization)
Time frame
within 7 days post procedure.4
Rate of intra-procedure airway bleeding graded using the Nashville Bleeding Scale
Time frame
Procedure dayOther outcomes
1
Rate of successful tool in lesion (TIL)
Time frame
During the index biopsy procedure.2
rEBUS view at time of tissue sampling (when radial EBUS is used)
Time frame
During the index biopsy procedure.3
Rate of procedure related adverse events.
Time frame
30 days post-procedure or until the next invasive diagnostic or therapeutic intervention, whichever occurs first.4
Time from identification of nodule to diagnosis
Time frame
Through establishment of final diagnosis (up to 12 months).Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: