Lung CancerNCT05867953
Assessment of Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System
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 2 sites in United Kingdom.
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. 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
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 20 Apr 2023to 4 Jun 2025
- 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 mediastinal or hilar lymphadenopathy requiring tissue biopsy on pre-procedure CT or positron emission tomography (PET)-CT scan.
- Patient with American Society of Anesthesiologists Classification (ASA) ≥4.
- Patient underwent a pneumonectomy.
- Any invasive concomitant procedure not related to the pulmonary nodule(s) or suspected disease state.
Show all 12Show fewer
- 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
2 sites in 1 country.
United Kingdom2 sites
Barts Health Nhs Trust
London, E1 1FR
Royal Brompton & Harefield Hospitals, Part of Guy'S and St Thomas' Nhs Foundation Trust
London, SW3 6NP
About this study
Official title: A Prospective Investigation to Assess the Accurate Tool Placement in Pulmonary Nodule(s) 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. Data on safety will also be collected.
Read the detailed description
This is a prospective, interventional, multicentre, single arm study which will be conducted in Europe and will involve up to 200 patients undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with 3D imaging.
The objectives of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including rate of tool in nodule, diagnostic accuracy, sensitivity for malignancy and safety.
All subjects will be followed up at 1 week and 1 month after the procedure. If the biopsy did not provide a diagnosis or did not show cancer and was still under observation at the 1 month visit, then they will have further follow up at 6 months. Similarly, if the status is unchanged (non-malignant diagnosis) at 6 months, the patients 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 Adjunct Real-time Imaging
| Study group | Role | What they receive |
|---|---|---|
| Biopsy Arm | 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.
Tool in Nodule
Rate of achieving biopsy tool position within the targeted nodule(s), documented by means of intraprocedural 3D imaging.
Defined as how often the biopsy needle used 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)
Secondary outcomes (2)
Diagnostic accuracy of sample(s) obtained
Diagnostic accuracy will be calculated as the rate of diagnosis made using samples obtained during the study procedure (true positives and true negatives) relative to the number of cases performed.
Diagnostic yield may also be reported in conjunction with diagnostic accuracy and calculated as the rate of malignant and benign diagnosis made relative to the number of cases performed; non-diagnostic samples will not be included in the numerator.
Measured: Up to 13 months post procedure
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start20 Apr 2023
- Primary completion11 Apr 2024
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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, multi-center, single-arm, interventional study
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT05867953
- Sponsor's protocol ID
- ISI-ION-EU1-2022
- Status last verified
- Sep 2025
- First submitted
- 21 Apr 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan LT, Lau KKW, Orton CM, Temov K, Tana A, Baboolal I, Karir A, Agaoglu E, Garner J, Kalyal A, Lapuente M, Ttofia F, Shah PL. Tool in lesion verification of shape-sensing robotic-assisted bronchoscopy with cone beam CT in sampling peripheral pulmonary nodules. Thorax. 2026 May 14;81(6):571-580. doi: 10.1136/thorax-2025-223631.
PubMed 41391887
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Investigation to Assess the Accurate Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System With Adjunct Real-time Imaging
- ClinicalTrials.gov ID
- NCT05867953
- Acronym / sponsor ID
- ISI-ION-EU1-2022
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Biopsy, Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 22 May 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. Data on safety will also be collected.
Detailed description
This is a prospective, interventional, multicentre, single arm study which will be conducted in Europe and will involve up to 200 patients undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with 3D imaging.
The objectives of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including rate of tool in nodule, diagnostic accuracy, sensitivity for malignancy and safety.
All subjects will be followed up at 1 week and 1 month after the procedure. If the biopsy did not provide a diagnosis or did not show cancer and was still under observation at the 1 month visit, then they will have further follow up at 6 months. Similarly, if the status is unchanged (non-malignant diagnosis) at 6 months, the patients 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, multi-center, single-arm, interventional study
| Arm | Type | Receives |
|---|---|---|
| Biopsy Arm | 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 (12 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 mediastinal or hilar lymphadenopathy requiring tissue biopsy on pre-procedure CT or positron emission tomography (PET)-CT scan.
- Patient with American Society of Anesthesiologists Classification (ASA) ≥4.
- Patient underwent a pneumonectomy.
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 Adjunct Real-time Imaging | Device | Biopsy Arm |
Primary outcome
Tool in Nodule
Time frame: At time of the biopsy procedure (Day 0)
Rate of achieving biopsy tool position within the targeted nodule(s), documented by means of intraprocedural 3D imaging. Defined as how often the biopsy needle used 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
2 secondary outcomes
Diagnostic accuracy of sample(s) obtained
Time frame: Up to 13 months post procedure
Sensitivity for malignancy of sample(s) obtained
Time frame: Up to 13 months post procedure
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 8 Sep 2025.
- Derived from this study: PubMed 41391887Chan LT, Lau KKW, Orton CM, Temov K, Tana A, Baboolal I, Karir A, Agaoglu E, Garner J, Kalyal A, Lapuente M, Ttofia F, Shah PL. Tool in lesion verification of shape-sensing robotic-assisted bronchoscopy with cone beam CT in sampling peripheral pulmonary nodules. Thorax. 2026 May 14;81(6):571-580. doi: 10.1136/thorax-2025-223631.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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
2 sites 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 2 sites in United Kingdom.
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 12 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Tool in Nodule (time frame: At time of the biopsy procedure (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05867953, which also lists 1 linked publication.
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 8 Sep 2025.