Lung CancerNCT05562895
A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy
An observational study of Lung Cancer, run by Intuitive Surgical at 6 sites in United States.
Trial summary
The overall objective of this study is to evaluate procedure characteristics of pulmonary nodule biopsies using the integrated version of Cios Spin and the Ion Endoluminal System. 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?
- Ion Endoluminal System and Cios Spin
- Type of treatment
- Medical device
- How many people
- 155 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Dec 2022to 31 Aug 2025
- Phase
- Observational
- 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
Study population: Subjects with an attempted or performed pulmonary nodule biopsy using the Ion Endoluminal System and Cios Spin, 18 years or older
Who may be able to join
- Subject is 18 years or older at the time of the procedure.
- Pulmonary nodule biopsy attempted/performed using the Ion Endoluminal System and Cios Spin 3D imaging.
- Pulmonary nodule ≤2 cm in largest diameter.
- Subject able to understand and adhere to study requirements and provide informed consent.
Who cannot join
- Planned lymph node staging performed before nodule biopsy.
- Nodule is a pure ground glass opacity.
- Plan to biopsy multiple nodules.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
South Austin Hospital
Austin, Texas, 78704
University of Alabama at Birmingham
Birmingham, Alabama, 35233
MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
University of California San Diego, Hillcrest Medical Center
San Diego, California, 92103
About this study
The overall objective of this study is to evaluate procedure characteristics of pulmonary nodule biopsies using the integrated version of Cios Spin and the Ion Endoluminal System.
Read the detailed description
This study is a post-market, prospective, multicenter, single-arm study of subjects undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with the Cios Spin. The aim of the study is to evaluate the integrated version of the two systems. The primary outcomes of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, sensitivity for malignancy, and rate of tool in nodule.
- Conditions
- Lung Cancer
- Being tested
- Ion Endoluminal System and Cios Spin
- 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 System and Cios SpinDevice
Integrated version of the Ion Endoluminal System and Cios Spin
| Study group | Role | What they receive |
|---|---|---|
| Subjects with biopsy of pulmonary nodule using Ion Endoluminal System and Cios Spin | Subjects in which a pulmonary nodule biopsy was attempted or performed with the integrated Ion Endoluminal System and Cios Spin Receives: Device: Ion Endoluminal System and Cios Spin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Defined as the sum of true positives and true negatives divided by the total number of nodules (or subjects) biopsied
Measured: Intra-procedure through the 13 month follow up period
Sensitivity for malignancy
Defined as the number of true positives divided by the sum of true positives and false negatives for malignancy
Measured: Intra-procedure through the 13 month follow up period
Rate of tool in nodule
Tool in nodule is defined as any portion of the needle visualized within the target in all 3 axes (must be confirmed with 3D imaging)
Measured: Intra-procedure
Secondary outcomes (2)
Total radiation dose
Radiation dose from biopsy procedure, measured by the dose area product (DAP), defined as the product of dose and beam area (Gy cm^2)
Measured: Intra-procedure
Time to achieve tool in nodule
Defined as the time the Ion catheter crosses the endotracheal tube (ETT) to the time tool in nodule is confirmed with 3D imaging
Measured: Intra-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start31 Dec 2022
- Primary completion31 Dec 2023
- Study completion31 Aug 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roberto Casal, MD, Principal investigator, MD AndersonBryan Husta, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562895
- Sponsor's protocol ID
- ISI-ION-002
- Status last verified
- Nov 2025
- First submitted
- 28 Sep 2022
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Husta BC, Cheng GZ, Batra H, Reisenauer JS, Bartek WM, Kalchiem-Dekel O, Zouk A, Patel N, Chawla M, Eapen GA, Jimenez CA, Lee RP, Bott MJ, Oh S, Casal RF. Shape-sensing robotic-assisted bronchoscopy with integrated mobile cone-beam CT for small nodules: results from the prospective multicentre CONFIRM study. Thorax. 2026 Feb 16;81(3):267-275. doi: 10.1136/thorax-2025-223272.
PubMed 41698810
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy
- ClinicalTrials.gov ID
- NCT05562895
- Acronym / sponsor ID
- ISI-ION-002
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 3 Oct 2022 (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 overall objective of this study is to evaluate procedure characteristics of pulmonary nodule biopsies using the integrated version of Cios Spin and the Ion Endoluminal System.
Detailed description
This study is a post-market, prospective, multicenter, single-arm study of subjects undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with the Cios Spin. The aim of the study is to evaluate the integrated version of the two systems. The primary outcomes of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, sensitivity for malignancy, and rate of tool in nodule.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with biopsy of pulmonary nodule using Ion Endoluminal System and Cios Spin | – | Device: Ion Endoluminal System and Cios SpinSubjects in which a pulmonary nodule biopsy was attempted or performed with the integrated Ion Endoluminal System and Cios Spin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with an attempted or performed pulmonary nodule biopsy using the Ion Endoluminal System and Cios Spin, 18 years or older
Key inclusion criteria (4 listed)
- Subject is 18 years or older at the time of the procedure.
- Pulmonary nodule biopsy attempted/performed using the Ion Endoluminal System and Cios Spin 3D imaging.
- Pulmonary nodule ≤2 cm in largest diameter.
- Subject able to understand and adhere to study requirements and provide informed consent.
Key exclusion criteria (3 listed)
- Planned lymph node staging performed before nodule biopsy.
- Nodule is a pure ground glass opacity.
- Plan to biopsy multiple nodules.
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 System and Cios SpinIntegrated version of the Ion Endoluminal System and Cios Spin | Device | Subjects with biopsy of pulmonary nodule using Ion Endoluminal System and Cios Spin |
Primary outcome
Diagnostic yield
Time frame: Intra-procedure through the 13 month follow up period
Defined as the sum of true positives and true negatives divided by the total number of nodules (or subjects) biopsied
Sensitivity for malignancy
Time frame: Intra-procedure through the 13 month follow up period
Defined as the number of true positives divided by the sum of true positives and false negatives for malignancy
Rate of tool in nodule
Time frame: Intra-procedure
Tool in nodule is defined as any portion of the needle visualized within the target in all 3 axes (must be confirmed with 3D imaging)
2 secondary outcomes
Total radiation dose
Time frame: Intra-procedure
Time to achieve tool in nodule
Time frame: Intra-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 13 Nov 2025.
- Derived from this study: PubMed 41698810Husta BC, Cheng GZ, Batra H, Reisenauer JS, Bartek WM, Kalchiem-Dekel O, Zouk A, Patel N, Chawla M, Eapen GA, Jimenez CA, Lee RP, Bott MJ, Oh S, Casal RF. Shape-sensing robotic-assisted bronchoscopy with integrated mobile cone-beam CT for small nodules: results from the prospective multicentre CONFIRM study. Thorax. 2026 Feb 16;81(3):267-275. doi: 10.1136/thorax-2025-223272.
- 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.
Roberto Casal, MD principal investigator
MD Anderson
Bryan Husta, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 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, run by Intuitive Surgical at 6 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 4 inclusion and 3 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 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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 (time frame: Intra-procedure through the 13 month follow up period). The study lists 3 primary outcomes in all. 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 NCT05562895, 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 13 Nov 2025.