Lung CancerNCT06084208
Assessment of Diagnostic Yield Using a Robotic Navigational Bronchoscopy System With CBCT
A study testing Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging in people with Lung Cancer, run by Intuitive Surgical at 1 site in Netherlands.
Trial summary
The aim of this research study is to evaluate the effectiveness of the ION endoluminal system at reaching and obtaining biopsies from lung nodules when used in combination with 3-dimensional imaging such as CT scans. The learning curve of the procedure will be assessed and data on safety will also be collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Sep 2023to 24 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is aged 18 years or older at time of consent.
- Patient is suitable for elective nodule biopsy via bronchoscopy under general anesthesia per Investigator's discretion.
- Patient has solid or semi-solid pulmonary nodule(s) of ≥6 mm and ≤3 cm in largest dimension (based on pre-procedure CT scan).
- Pulmonary nodule(s) intended for biopsy during the study procedure is (are) located at least 4 (≥4) airway generations out (trachea = generation 0, e.g. subsegmental bronchi or beyond) based on pre-procedure CT scan.
- Patient has a moderate to high risk of lung cancer based on clinical, demographic, and radiologic information or with suspected metastatic disease. High risk for malignancy patients are eligible if a biopsy is required or requested prior to intervention.
- Patient is willing and able to give written informed consent for Clinical Investigation participation.
- Patient is not legally incapacitated or in a legal/court ordered institution.
Who cannot join
- Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by Investigator prior to procedure.
- Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsy during study procedure.
- Presence of bullae(s) with a size of >1 cm on pre-procedure CT scan located in close proximity to target nodule(s) and near the planned trajectory of the biopsy instruments.
- Presence of mediastinal nodal disease on pre-procedure CT or PET-CT scan.
- Patient with American Society of Anesthesiologists Classification (ASA) ≥4.
- Patient underwent a pneumonectomy.
Show all 13Show fewer
- Any invasive concomitant procedure (outside of lymph node staging) not related to the pulmonary nodule(s) or suspected disease state.
- Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding.
- Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder.
- Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice.
- Patient is currently participating or has participated in another Clinical Investigation within the past 30 days, such as interventional trials or trials with experimental agents or agents of unknown risk, that may affect the endpoints of this Clinical Investigation.
- Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the Clinical Investigation.
- Patient is not willing to comply with post study procedure participation requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Investigation to Assess the Diagnostic Yield of Using a Robotic Navigational Bronchoscopy System With Adjunct Real-time Imaging
The aim of this research study is to evaluate the effectiveness of the ION endoluminal system at reaching and obtaining biopsies from lung nodules when used in combination with 3-dimensional imaging such as CT scans. The learning curve of the procedure will be assessed and data on safety will also be collected.
Read the detailed description
This is a prospective, interventional, single-centre, dual-arm study which will be conducted in the Netherlands and will involve up to 131 patients undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with 3D imaging. Outcomes in these patients will be compared to 91 propensity score matched Cone Beam CT- Navigational Bronchoscopy (CBCT-NB) controls obtained from the site's existing CBCT-NB database.
The objectives of the study are focused on evaluating the procedure learning curve and characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, rate of tool in nodule, sensitivity for malignancy and safety.
A learning curve analysis will be retrospectively performed to determine when both operators have reached competency with the Ion Endoluminal System. Criteria for passing the learning curve for measuring proficiency in the CUSUM will be diagnostic yield. Additional parameters like tool in lesion and procedure durations will also be monitored.
All subjects will be followed up at 1 week after the procedure. If an adverse event was observed, a 30-day post-procedure visit will also take place. If the biopsy did not provide a diagnosis or did not show cancer and was still under observation, then they will have further follow up at 6 months. Similarly, if the status is unchanged (non-malignant diagnosis) and the nodule is still under observation, a 13 months visit should be completed.
- Conditions
- Lung Cancer
- Being tested
- Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging
- Keywords
- Lung Cancer, Biopsy, Bronchoscopy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time ImagingDevice
Biopsy with the Robotic- Navigational Bronchoscopy System with Cone Beam Computed Tomography (CBCT)
| Study group | Role | What they receive |
|---|---|---|
| Robotic Navigational Bronchoscopy | Experimental | Patients undergoing biopsy with the Ion Endoluminal System Receives: Device: Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of sample(s) obtained (post learning curve)
Diagnostic yield is the number of nodules in which the procedure was diagnostic (either malignant or non-malignant), relative to the total number of attempted navigation procedures
Measured: Up to 13 months post procedure]
Secondary outcomes (2)
Sensitivity for malignancy of sample(s) obtained
Sensitivity for malignancy of samples is assessed as the number of subjects with a malignant condition determined through the study procedure (true positives) relative to the number of subjects with an underlying malignant disease state (true positives + false negatives).
The subjects underlying disease state will be determined by follow-up diagnostic interventions or treatment decisions/interventions, and/or radiographic follow-up.
Measured: Up to 13 months post procedure
Rate of achieving biopsy tool position within the targeted nodule(s) as confirmed by CBCT 3D imaging or the combination of multi-angle augmented fluoroscopy with diagnostic rapid onsite pathology (in the absence of a confirmatory spin).
The rate of Tool in Nodule is how often the biopsy tool to sample the tissue is positioned directly within the nodule before the sample is taken.
If biopsy forceps are used, it is how often the instrument is surrounding the nodule before the sample is taken.
Measured: At time of the biopsy procedure (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start15 Sep 2023
- Primary completion24 Jan 2025
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, single-center, dual-arm, interventional study, where data from 131 recruited patients undergoing a Robotic Navigational Bronchoscopy System procedure with CBCT are compared to 91 matched Navigation Bronchoscopy with CBCT controls.
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sundeep Master, Study director, Intuitive Surgical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084208
- Sponsor's protocol ID
- ISI-ION-EU2-2023
- Status last verified
- Jul 2026
- First submitted
- 20 Sep 2023
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Investigation to Assess the Diagnostic Yield of Using a Robotic Navigational Bronchoscopy System With Adjunct Real-time Imaging
- ClinicalTrials.gov ID
- NCT06084208
- Acronym / sponsor ID
- ISI-ION-EU2-2023
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Biopsy, Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 16 Oct 2023 (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 aim of this research study is to evaluate the effectiveness of the ION endoluminal system at reaching and obtaining biopsies from lung nodules when used in combination with 3-dimensional imaging such as CT scans. The learning curve of the procedure will be assessed and data on safety will also be collected.
Detailed description
This is a prospective, interventional, single-centre, dual-arm study which will be conducted in the Netherlands and will involve up to 131 patients undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with 3D imaging. Outcomes in these patients will be compared to 91 propensity score matched Cone Beam CT- Navigational Bronchoscopy (CBCT-NB) controls obtained from the site's existing CBCT-NB database.
The objectives of the study are focused on evaluating the procedure learning curve and characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, rate of tool in nodule, sensitivity for malignancy and safety.
A learning curve analysis will be retrospectively performed to determine when both operators have reached competency with the Ion Endoluminal System. Criteria for passing the learning curve for measuring proficiency in the CUSUM will be diagnostic yield. Additional parameters like tool in lesion and procedure durations will also be monitored.
All subjects will be followed up at 1 week after the procedure. If an adverse event was observed, a 30-day post-procedure visit will also take place. If the biopsy did not provide a diagnosis or did not show cancer and was still under observation, then they will have further follow up at 6 months. Similarly, if the status is unchanged (non-malignant diagnosis) and the nodule is still under observation, a 13 months visit should be completed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, single-center, dual-arm, interventional study, where data from 131 recruited patients undergoing a Robotic Navigational Bronchoscopy System procedure with CBCT are compared to 91 matched Navigation Bronchoscopy with CBCT controls.
| Arm | Type | Receives |
|---|---|---|
| Robotic Navigational Bronchoscopy | Experimental | Device: Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time ImagingPatients undergoing biopsy with the Ion Endoluminal System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is aged 18 years or older at time of consent.
- Patient is suitable for elective nodule biopsy via bronchoscopy under general anesthesia per Investigator's discretion.
- Patient has solid or semi-solid pulmonary nodule(s) of ≥6 mm and ≤3 cm in largest dimension (based on pre-procedure CT scan).
- Pulmonary nodule(s) intended for biopsy during the study procedure is (are) located at least 4 (≥4) airway generations out (trachea = generation 0, e.g. subsegmental bronchi or beyond) based on pre-procedure CT scan.
- Patient has a moderate to high risk of lung cancer based on clinical, demographic, and radiologic information or with suspected metastatic disease. High risk for malignancy patients are eligible if a biopsy is required or requested prior to intervention.
Key exclusion criteria (13 listed)
- Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by Investigator prior to procedure.
- Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsy during study procedure.
- Presence of bullae(s) with a size of >1 cm on pre-procedure CT scan located in close proximity to target nodule(s) and near the planned trajectory of the biopsy instruments.
- Presence of mediastinal nodal disease on pre-procedure CT or PET-CT scan.
- Patient with American Society of Anesthesiologists Classification (ASA) ≥4.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time ImagingBiopsy with the Robotic- Navigational Bronchoscopy System with Cone Beam Computed Tomography (CBCT) | Device | Robotic Navigational Bronchoscopy |
Primary outcome
Diagnostic yield of sample(s) obtained (post learning curve)
Time frame: Up to 13 months post procedure]
Diagnostic yield is the number of nodules in which the procedure was diagnostic (either malignant or non-malignant), relative to the total number of attempted navigation procedures
2 secondary outcomes
Sensitivity for malignancy of sample(s) obtained
Time frame: Up to 13 months post procedure
Rate of achieving biopsy tool position within the targeted nodule(s) as confirmed by CBCT 3D imaging or the combination of multi-angle augmented fluoroscopy with diagnostic rapid onsite pathology (in the absence of a confirmatory spin).
Time frame: At time of the biopsy procedure (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No. No plan to share IPD.
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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. This study is not recruiting at the moment.
Sundeep Master study director
Intuitive Surgical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging in people with Lung Cancer, run by Intuitive Surgical at 1 site in Netherlands.
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 7 inclusion and 13 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: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of sample(s) obtained (post learning curve) (time frame: Up to 13 months post 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 15 Jul 2026.