Lung CancerNCT06004440
Real World Registry for Use of the Ion Endoluminal System
An observational study of Lung Cancer and Multiple Pulmonary Nodules, run by Intuitive Surgical at 16 sites in United States.
Trial summary
The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Multiple Pulmonary Nodules, Lung Neoplasms
- What is being tested?
- Ion Endoluminal System
- Type of treatment
- Medical device
- How many people
- 1,301 participants
- Where
- 16 sitesUnited States
- Study dates
- 21 Sep 2023to Aug 2028
- How long will I take part?
- 2 Years
- 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: Subjects scheduled for an elective pulmonary lesion biopsy or localization procedure using the Ion Endoluminal System, 18 years or older
Who may be able to join
- Subject is 18 years or older at the time of the index procedure.
- Subject is a candidate for an elective, planned lung lesion localization or biopsy procedure utilizing the Ion Endoluminal System.
- Subject able to understand and adhere to study requirements and provide informed consent.
Who cannot join
- Subject is under the care of a Legally Authorized Representative (LAR) and is unable to provide informed consent on their own accord.
- Subject is participating in an interventional research study or research study investigational agents with an unknown safety profile that would interfere with participation in this study.
- Female subjects who are pregnant or nursing at the time of the index bronchoscopy procedure, as determined by standard site practices.
- Subjects that are incarcerated or institutionalized under court order, or other vulnerable populations.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Mercy Hospital of Buffalo
Buffalo, New York, 14220
Atrium Health of the Carolinas
Charlotte, North Carolina, 28203
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Henry Ford Hospital
Detroit, Michigan, 48202
Ascension Alexian Brothers
Elk Grove Village, Illinois, 60007
Cone Health Moses Cone Memorial Hospital
Greensboro, North Carolina, 27401
Kansas University Medical Center
Kansas City, Kansas, 66103
Aurora Medical Center Kenosha
Kenosha, Wisconsin, 53143
Intermountain Medical Center
Murray, Utah, 84107
Centennial Medical Center
Nashville, Tennessee, 37203
Tulane University
New Orleans, Louisiana, 70112
Orlando Health Orlando Regional Medical Center
Orlando, Florida, 32806
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
Blessing Hospital
Quincy, Illinois, 62301
Mayo Clinic
Rochester, Minnesota, 55902
Methodist Hospital
San Antonio, Texas, 78229
About this study
Official title: A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System
The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.
Read the detailed description
This study is a single-arm, post-market, prospective, multi-center, observational study of subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or biopsy procedure with the Ion Endoluminal System. The primary outcome of this study is focused on evaluating the performance characteristics of the pulmonary lesion biopsy procedure as evaluated by diagnostic yield.
Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60.
- Conditions
- Lung Cancer, Multiple Pulmonary Nodules, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site
- Being tested
- Ion Endoluminal System
- Keywords
- pulmonary biopsy, pulmonary lesion localization, shape sensing robotic assisted bronchoscopy, ION, Intuitive
- Medical subject headings
- Lung Neoplasms, Multiple Pulmonary Nodules, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ion Endoluminal SystemDevice
Subjects will under a planned procedure with the Ion Endoluminal System
| Study group | Role | What they receive |
|---|---|---|
| Subjects with biopsy, with or without localization, of pulmonary lesion using Ion Endoluminal System | Subjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System. Receives: Device: Ion Endoluminal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint to Assess 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 the 24 month follow up period
Secondary outcomes (2)
Secondary Endpoint to Assess Pneumothorax
Defined as the incidence of subjects that undergo an Ion Procedure with a pneumothorax event, requiring intervention
Measured: Intra-procedure through the 30 day follow up period
Secondary Endpoint to Assess 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 follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start21 Sep 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,301 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janani Reisenauer, MD, Study chair, Mayo ClinicMichael Pritchett, DO, MPH, Study chair, FirstHealth of the Carolinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004440
- Sponsor's protocol ID
- ISI-ION-003
- Status last verified
- Apr 2026
- First submitted
- 16 Aug 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System
- ClinicalTrials.gov ID
- NCT06004440
- Acronym / sponsor ID
- ISI-ION-003
- Conditions
- Lung Cancer, Multiple Pulmonary Nodules, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site
- Keywords
- pulmonary biopsy, pulmonary lesion localization, shape sensing robotic assisted bronchoscopy, ION, Intuitive
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,301 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 22 Aug 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 primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.
Detailed description
This study is a single-arm, post-market, prospective, multi-center, observational study of subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or biopsy procedure with the Ion Endoluminal System. The primary outcome of this study is focused on evaluating the performance characteristics of the pulmonary lesion biopsy procedure as evaluated by diagnostic yield.
Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with biopsy, with or without localization, of pulmonary lesion using Ion Endoluminal System | – | Device: Ion Endoluminal SystemSubjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects scheduled for an elective pulmonary lesion biopsy or localization procedure using the Ion Endoluminal System, 18 years or older
Key inclusion criteria (3 listed)
- Subject is 18 years or older at the time of the index procedure.
- Subject is a candidate for an elective, planned lung lesion localization or biopsy procedure utilizing the Ion Endoluminal System.
- Subject able to understand and adhere to study requirements and provide informed consent.
Key exclusion criteria (4 listed)
- Subject is under the care of a Legally Authorized Representative (LAR) and is unable to provide informed consent on their own accord.
- Subject is participating in an interventional research study or research study investigational agents with an unknown safety profile that would interfere with participation in this study.
- Female subjects who are pregnant or nursing at the time of the index bronchoscopy procedure, as determined by standard site practices.
- Subjects that are incarcerated or institutionalized under court order, or other vulnerable populations.
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 SystemSubjects will under a planned procedure with the Ion Endoluminal System | Device | Subjects with biopsy, with or without localization, of pulmonary lesion using Ion Endoluminal System |
Primary outcome
Primary Endpoint to Assess Diagnostic Yield
Time frame: Intra-procedure through the 24 month follow up period
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
Secondary Endpoint to Assess Pneumothorax
Time frame: Intra-procedure through the 30 day follow up period
Secondary Endpoint to Assess Bleeding
Time frame: Intra-procedure through the 30 day follow up period
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 24 Apr 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. This study is not recruiting at the moment.
Janani Reisenauer, MD study chair
Mayo Clinic
Michael Pritchett, DO, MPH study chair
FirstHealth of the Carolinas
16 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 and Multiple Pulmonary Nodules, run by Intuitive Surgical at 16 sites in United States.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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?
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?
Primary Endpoint to Assess Diagnostic Yield (time frame: Intra-procedure through the 24 month follow up period). 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 24 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.