Lung CancerNCT05546437
A Multicenter Retrospective Review to Evaluate the Feasibility of Dye Marking Using the Ion Endoluminal System
An observational study of Lung Cancer, run by Intuitive Surgical at 1 site in United States.
Trial summary
The overall objective of this study is to assess the ability of the Ion Endoluminal System to perform pleural based tissue dye marking in anticipation of a lung resection. 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
- Type of treatment
- Medical device
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2022to 31 Dec 2023
- 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 who underwent an Ion Endoluminal dye marking procedure with a pulmonary nodule, 18 years or older, who subsequently underwent a resection of their pulmonary nodule.
Who may be able to join
- Subject is 18 years or older at the time of the procedure.
- Dye marking attempted/performed using the Ion Endoluminal Platform
Who cannot join
- Resection not performed following dye marking procedure
Trial locations and contacts
1 site in 1 country.
About this study
The overall objective of this study is to assess the ability of the Ion Endoluminal System to perform pleural based tissue dye marking in anticipation of a lung resection.
Read the detailed description
This study is a retrospective multicenter chart review of patients who underwent a pleural based tissue dye marking with the Ion Endoluminal System in anticipation of lung resection. The aim of the study is to assess the feasibility of the Ion Endoluminal System to perform pleural based tissue marking. As this is a retrospective study, the Ion dye marking procedure will have been performed according to the physician's standard technique. All consecutive cases in which a dye marking procedure was attempted and/or completed with the Ion Endoluminal System will be included.
- Conditions
- Lung Cancer
- Being tested
- Ion Endoluminal System
- 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
Ion Endoluminal dye marking procedure for pulmonary nodule
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Ion Endoluminal dye marking of pulmonary nodule for resection | Subjects in which a pulmonary lesion dye marking procedure was attempted or performed with the Ion Endoluminal System in anticipation of resection of the lesion Receives: Device: Ion Endoluminal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful dye injection
The ability of the investigator to localize the marked lesion during resection, assessed by successful injection of dye, localization of due within the targeted area, and the ability to visualize the dye marking intra-operatively or on resected sample
Measured: Intra-procedure through the release of the final pathology report, approximately 3 days post-procedure
Pneumothorax
Incidence of all pneumothoraces related to the Ion procedure
Measured: Intra-procedure
Secondary outcomes (5)
Adverse events
All adverse events related to the Ion procedure
Measured: Intra-procedure until the start of the resection procedure
Procedure time
Time from start of Ion dye marking procedure (defined as when the Ion catheter crosses the endotracheal tube [ETT]) to end of Ion dye marking procedure (defined as when the Ion catheter leaves the ETT).
Measured: Intra-procedure
Operative time
Time from start of resection procedure to end of resection procedure (skin-to-skin time)
Measured: Intra-operative
Type of resection planned and performed
The type of resection procedure planned (ex., lobectomy, wedge resection) and whether that plan was altered after the dye marking procedure or resection has started.
Measured: Intra-operative
Conversion to alternate approach or termination of procedure due to localization issues
Rate of resections converted to an alternative approach or terminated. Conversion is defined as a change in the procedural approach (either a different technology [ex., open resection] after the resection procedure has started. Termination is defined as prematurely ending the operation before the resection has been performed.
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start22 Jul 2022
- Primary completion30 Apr 2023
- Study completion31 Dec 2023
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546437
- Sponsor's protocol ID
- ISI-ION-R02
- Status last verified
- Mar 2024
- First submitted
- 14 Sep 2022
- Last updated
- 8 Mar 2024
- 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 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Retrospective Review to Evaluate the Feasibility of Dye Marking Using the Ion Endoluminal System
- ClinicalTrials.gov ID
- NCT05546437
- Acronym / sponsor ID
- ISI-ION-R02
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Sep 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 assess the ability of the Ion Endoluminal System to perform pleural based tissue dye marking in anticipation of a lung resection.
Detailed description
This study is a retrospective multicenter chart review of patients who underwent a pleural based tissue dye marking with the Ion Endoluminal System in anticipation of lung resection. The aim of the study is to assess the feasibility of the Ion Endoluminal System to perform pleural based tissue marking. As this is a retrospective study, the Ion dye marking procedure will have been performed according to the physician's standard technique. All consecutive cases in which a dye marking procedure was attempted and/or completed with the Ion Endoluminal System will be included.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Ion Endoluminal dye marking of pulmonary nodule for resection | – | Device: Ion Endoluminal SystemSubjects in which a pulmonary lesion dye marking procedure was attempted or performed with the Ion Endoluminal System in anticipation of resection of the lesion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who underwent an Ion Endoluminal dye marking procedure with a pulmonary nodule, 18 years or older, who subsequently underwent a resection of their pulmonary nodule.
Key inclusion criteria (2 listed)
- Subject is 18 years or older at the time of the procedure.
- Dye marking attempted/performed using the Ion Endoluminal Platform
Key exclusion criteria (1 listed)
- Resection not performed following dye marking procedure
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 SystemIon Endoluminal dye marking procedure for pulmonary nodule | Device | Subjects with Ion Endoluminal dye marking of pulmonary nodule for resection |
Primary outcome
Successful dye injection
Time frame: Intra-procedure through the release of the final pathology report, approximately 3 days post-procedure
The ability of the investigator to localize the marked lesion during resection, assessed by successful injection of dye, localization of due within the targeted area, and the ability to visualize the dye marking intra-operatively or on resected sample
Pneumothorax
Time frame: Intra-procedure
Incidence of all pneumothoraces related to the Ion procedure
5 secondary outcomes
Adverse events
Time frame: Intra-procedure until the start of the resection procedure
Procedure time
Time frame: Intra-procedure
Operative time
Time frame: Intra-operative
Type of resection planned and performed
Time frame: Intra-operative
Conversion to alternate approach or termination of procedure due to localization issues
Time frame: Intra-operative
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 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 1 site 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 2 inclusion and 1 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 Mar 2024. 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 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?
Successful dye injection (time frame: Intra-procedure through the release of the final pathology report, approximately 3 days post-procedure). The study lists 2 primary outcomes in all. 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 8 Mar 2024.