Lung CancerNCT05160571
A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions
An observational study of Lung Cancer and Pulmonary Nodule, run by Intuitive Surgical at 1 site in United States.
Trial summary
This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Pulmonary Nodule
- What is being tested?
- Ion Endoluminal System
- Type of treatment
- Medical device
- How many people
- 279 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 31 Dec 2022
- 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 Procedure with a pulmonary nodule, 18 years or older
Who may be able to join
- Subject was 18 years or older at the time of the procedure
- Biopsy procedure attempted/performed using the Ion Endoluminal System
Who cannot join
- Biopsy procedure was not attempted with the Ion Endoluminal System
- Biopsy procedure attempted with the Ion Endoluminal System occurred less than 12 months prior to IRB approval
Trial locations and contacts
1 site in 1 country.
United States1 site
Winchester Medical Center
Winchester, Virginia, 22601
About this study
This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system.
Read the detailed description
This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system. The primary objectives of the study will be performance (evaluated by diagnostic yield and sensitivity for malignancy) and safety (assessed by rate of pneumothoraces and bleeding events).
- Conditions
- Lung Cancer, Pulmonary Nodule
- 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 Procedure for pulmonary nodule
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Ion Endoluminal sampling of pulmonary nodule | Subjects in which a pulmonary lesion biopsy 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.
Diagnostic yield
Diagnostic yield of the sample obtained through the bronchoscopy procedure, with diagnostic yield defined as (true positives + true negatives)/(total number of lesions biopsied)
Measured: Intra-operative through the one year follow up period
Sensitivity for malignancy
Sensitivity for malignancy of the sample obtained
Measured: Intra-operative through the one year follow up period
Pneumothorax
Incidence of all pneumothoraces related to the Ion procedure
Measured: Intra-operative
Bleeding
Incidence of bleeding in which an intervention was required, related to the Ion procedure. Interventions include: administration of cold saline, vasoactive substances, thrombin, or similar in response to active bleeding; use of bronchial/balloon blocker; use of bronchial artery embolization or resuscitation or ICU admission.
Measured: Intra-operative
Secondary outcomes (2)
Adverse events
All adverse events related to the Ion procedure
Measured: Intra-operative through 30 days
Conversion to alternate approach or termination of procedure
Rate of procedures converted to an alternative approach or terminated. Conversion is defined as a change in the procedural approach (either a different technology [ex., electromagnetic navigational bronchoscopy] or a different procedure [ex., CT-guided transthoracic needle aspiration]) after the Ion catheter has entered the endotracheal tube. Termination is defined as prematurely ending the procedure after the Ion catheter has entered the endotracheal tube but before the biopsy sample has been obtained.
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 posted16 Dec 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glen Bouder, MD, Principal investigator, Winchester Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160571
- Sponsor's protocol ID
- ISI-ION-R01
- Status last verified
- Mar 2023
- First submitted
- 15 Dec 2021
- Last updated
- 3 Mar 2023
- 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 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT05160571
- Acronym / sponsor ID
- ISI-ION-R01
- Conditions
- Lung Cancer, Pulmonary Nodule
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Dec 2021 (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.
This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system.
Detailed description
This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system. The primary objectives of the study will be performance (evaluated by diagnostic yield and sensitivity for malignancy) and safety (assessed by rate of pneumothoraces and bleeding events).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Ion Endoluminal sampling of pulmonary nodule | – | Device: Ion Endoluminal SystemSubjects in which a pulmonary lesion biopsy 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 who underwent an Ion Endoluminal Procedure with a pulmonary nodule, 18 years or older
Key inclusion criteria (2 listed)
- Subject was 18 years or older at the time of the procedure
- Biopsy procedure attempted/performed using the Ion Endoluminal System
Key exclusion criteria (2 listed)
- Biopsy procedure was not attempted with the Ion Endoluminal System
- Biopsy procedure attempted with the Ion Endoluminal System occurred less than 12 months prior to IRB approval
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 Procedure for pulmonary nodule | Device | Subjects with Ion Endoluminal sampling of pulmonary nodule |
Primary outcome
Diagnostic yield
Time frame: Intra-operative through the one year follow up period
Diagnostic yield of the sample obtained through the bronchoscopy procedure, with diagnostic yield defined as (true positives + true negatives)/(total number of lesions biopsied)
Sensitivity for malignancy
Time frame: Intra-operative through the one year follow up period
Sensitivity for malignancy of the sample obtained
Pneumothorax
Time frame: Intra-operative
Incidence of all pneumothoraces related to the Ion procedure
Bleeding
Time frame: Intra-operative
Incidence of bleeding in which an intervention was required, related to the Ion procedure. Interventions include: administration of cold saline, vasoactive substances, thrombin, or similar in response to active bleeding; use of bronchial/balloon blocker; use of bronchial artery embolization or resuscitation or ICU admission.
2 secondary outcomes
Adverse events
Time frame: Intra-operative through 30 days
Conversion to alternate approach or termination of procedure
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 3 Mar 2023.
- 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.
Glen Bouder, MD principal investigator
Winchester Medical Center
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 and Pulmonary Nodule, 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 2 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 3 Mar 2023. 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?
Diagnostic yield (time frame: Intra-operative through the one year follow up period). The study lists 4 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 3 Mar 2023.