Pulmonary NoduleNCT06923774
European Real-World Registry for Use of the Ion Endoluminal System
An observational study of Pulmonary Nodule and Lung Cancer, run by Intuitive Surgical at 9 sites in 4 countries.
Trial summary
The objective of this study is to collect collect real-world data for the Ion endoluminal system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodule, Lung Cancer
- What is being tested?
- Ion endoluminal system
- Type of treatment
- Medical device
- How many people
- 1,200 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 9 Sep 2025to Oct 2029
- How long will I take part?
- 24 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients planned for an elective lung nodule biopsy and/or localization procedure using the Ion endoluminal system as their standard of care
Who may be able to join
- Patient is aged 18 years or older at time of consent.
- Patient is planned to undergo a lung lesion biopsy(s) and/or localization procedure(s) utilizing the Ion endoluminal system.
- Patient is willing and able to give written informed consent for clinical study participation.
Who cannot join
- Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results.
- Female patient that is pregnant or breast feeding as determined by standard site practices.
- 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, hospital or study doctor.
- Patient is not willing to comply with post-procedure study participation requirements.
- Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the clinical study.
Trial locations and contacts
9 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 4 countries
France3 sites, 3 recruiting
- Not yet recruiting
CHU de Brest, Hôpital de La Cavale Blanche
Brest, 29200
Christophe Gut-Gobert, Dr.
- Recruiting
Hôpital Marie Lannelongue
Le Plessis-Robinson, 92350
Amir Hanna, Dr.
- Not yet recruiting
CHU de Rouen
Rouen, 76031
Samy Lachkar, Dr.
Germany3 sites, 3 recruiting
- Recruiting
Helios Klinikum Emil von Behring
Berlin, 14165
Joanna Krist, Dr.
- Recruiting
DGD Lungenklining Hemer
Hemer, 58675
Kaid Darwiche, Prof. Dr.
- Recruiting
Helios Dr. Horst Schmidt Kliniken
Wiesbaden, 65199
Tim Hirche, Prof. Dr.
United Kingdom2 sites, 2 recruiting
- Recruiting
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
Ricky Thakrar, Dr.
- Recruiting
Wythenshawe Hospital, Manchester University NHS Foundation Trust
Manchester, M23 9LT
Haval Balata, Dr.
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsspital Zürich
Zurich, 8091
Carolin Steinack, PD Dr.
About this study
Official title: A European Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Ion Endoluminal System
The objective of this study is to collect collect real-world data for the Ion endoluminal system.
Read the detailed description
This is a prospective, observational, multi-center, single-arm study to collect real-world data evaluating procedural characteristics and short- and long-term clinical outcomes following the use of the CE-marked Ion endoluminal system for elective lung nodule biopsies and/or localization procedures. It is a post-market study using the device per the approved indications. All patients will be enrolled per the protocol eligibility criteria. Enrollment for this study will conclude when approximately 1,200 patients have had a nodule biopsy and/or localization procedure attempted or performed.
- Conditions
- Pulmonary Nodule, Lung Cancer
- Being tested
- Ion endoluminal system
- Keywords
- Biopsy, Bronchoscopy, pulmonary biopsy, pulmonary nodule localization
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ion endoluminal systemDevice
Lung nodule biopsy and/or localization procedure using the Ion endoluminal system per sites' standard of care
| Study group | Role | What they receive |
|---|---|---|
| Observation Group | Subjects with biopsy and/or localization of lung nodule(s) Receives: Device: Ion endoluminal system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield
Diagnostic Yield defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only.
Measured: Intra-procedure through 24 month post-procedure
Secondary outcomes (2)
Pneumothorax
Defined as the incidence of subjects that undergo an Ion procedure with a pneumothorax event, requiring intervention
Measured: Intra-procedure through 30 days post-procedure
Bleeding
Defined as the incidence of subjects that undergo an Ion Procedure with a bleeding event, with a grade of greater than 2 on the Nashville Scale
Measured: Intra-procedure through the 30 day post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start9 Sep 2025
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NoduleStudies 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
- 1,200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923774
- Sponsor's protocol ID
- 1147383C
- Status last verified
- Nov 2025
- First submitted
- 4 Apr 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A European Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Ion Endoluminal System
- ClinicalTrials.gov ID
- NCT06923774
- Acronym / sponsor ID
- 1147383C
- Conditions
- Pulmonary Nodule, Lung Cancer
- Keywords
- Biopsy, Bronchoscopy, pulmonary biopsy, pulmonary nodule localization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 11 Apr 2025 (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 objective of this study is to collect collect real-world data for the Ion endoluminal system.
Detailed description
This is a prospective, observational, multi-center, single-arm study to collect real-world data evaluating procedural characteristics and short- and long-term clinical outcomes following the use of the CE-marked Ion endoluminal system for elective lung nodule biopsies and/or localization procedures. It is a post-market study using the device per the approved indications. All patients will be enrolled per the protocol eligibility criteria. Enrollment for this study will conclude when approximately 1,200 patients have had a nodule biopsy and/or localization procedure attempted or performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation Group | – | Device: Ion endoluminal systemSubjects with biopsy and/or localization of lung nodule(s) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planned for an elective lung nodule biopsy and/or localization procedure using the Ion endoluminal system as their standard of care
Key inclusion criteria (3 listed)
- Patient is aged 18 years or older at time of consent.
- Patient is planned to undergo a lung lesion biopsy(s) and/or localization procedure(s) utilizing the Ion endoluminal system.
- Patient is willing and able to give written informed consent for clinical study participation.
Key exclusion criteria (5 listed)
- Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results.
- Female patient that is pregnant or breast feeding as determined by standard site practices.
- 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, hospital or study doctor.
- Patient is not willing to comply with post-procedure study participation requirements.
- Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the clinical study.
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 |
|---|---|---|
| Ion endoluminal systemLung nodule biopsy and/or localization procedure using the Ion endoluminal system per sites' standard of care | Device | Observation Group |
Primary outcome
Diagnostic Yield
Time frame: Intra-procedure through 24 month post-procedure
Diagnostic Yield defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only.
2 secondary outcomes
Pneumothorax
Time frame: Intra-procedure through 30 days post-procedure
Bleeding
Time frame: Intra-procedure through the 30 day post-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 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodule and Lung Cancer, run by Intuitive Surgical at 9 sites in 4 countries.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 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 9 sites in France, Germany, United Kingdom, Switzerland. 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 Jana Meschede (+41 21 821 2000, IonEURegistry@intusurg.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Yield (time frame: Intra-procedure through 24 month 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 9 Oct 2026.